Talk:Ciprofloxacin/Archive 1

Archive 1

Thank you

Just wanted to post a thank you to all who have been watching the fluoroquinolone articles develop and for the time they have spent repairing spelling and grammar errors and the like. Much appreciated. We are working on all of the fluoroquinolone articles to bring them up to date and are following a similar format for all of them. Any suggestions would be appreciated and invite those who are helping to post such suggestions on the various quinolone talk pages for consideration. Again, thanks for your efforts here folks. Davidtfull (talk) 20:05, 11 April 2009 (UTC)

corrective editing currently in progress

Editing of this article is in progress to remove inadvertent OR as well as provide for a more NPOV. Citations are in the process of being verified, added or changed as needed, text not supported by citations will be removed. Would ask other editors not to edit the article while this task is in progress. Please post any concerns on this talk page, rather than editing, as they may have already been addressed and corrected, but the changes not yet completed and applied. Please allow us time to correct what needs to be corrected in an orderly fashion as we are aware of the articles numerous shortcomings and are working diligently to correct them as time allows.Davidtfull (talk) 06:24, 3 March 2009 (UTC)

section designations in use

To keep the information consistant for this class a section designation incorporating the one wiki uses for drugs, and the addition of headings relevant to this class had been developed. Cipro and levaquin were the first drugs in this class that this was applied to. Some really good edits had been made that improves upon this within the cipro article so I am in the process of incorporating them into the levaquin article and changing the two accordingly so that they will once again be the same when it comes to the headings being used.Davidtfull (talk) 01:18, 2 March 2009 (UTC)

recent change to the ciprofloxacin page

I appreciate this recent edit as it added the fact that cipro is available OTC in Mexico, but do we think it to be approriate to add a picture that promotes a particular brand named drug? I would assume that was not the persons intention, but that is the final result. Would we not agree that the article should remain free of any free advertisment for the various manufacturers?Davidtfull (talk) 09:19, 16 February 2009 (UTC)

Thanks for sharing your concerns. Its not a brand name version of the drug, rather the name Ciprofloxacino is the name of the generic in Mexico. In selecting a photo, I tried to select one that didn't display any brand names, manufacturer names and/or logos. The purpose of the photo was to show an example of the medication itself and its common packaging. Precidence exists, as there are similar photographs of medications and packaging in articles about other antibiotics such as Amoxicillin and even the common analgesic Acetaminophen. I reviewed the photo, and realized it wasn't clear from subtitle that Ciprofloxacino is the Spanish translation of Ciprofloxacin, and therefore have changed it. However, if there is a overall opposition to having the photo of generic packaging and tablets, I have nothing against removing it. --Nsaum75 (talk) 11:04, 16 February 2009 (UTC)

Editing for Brevity

I believe that all of the relevant data has been added to this article with my last update. However, the article now needs to be severely edited for brevity. We are currently at about 90 kbs, and as such we need to reduce the total article length to less than 80 kb by elminiating duplicate information, excessive verbage, frivolous information, etc. I thought it best to present all of the relevant data first, before attempting to pair the article down to size, so that we would be able to make intellegent decisions regarding what to leave in and what to leave out, as well as leave room for future revisions. We should shoot for an article about 60-70kb in lenght when it is all said and done. It is not my intention to leave this article this bloated and will be making surgical edits of each stub as I find the time. I intend to do the same with the Levaquin, quinolone, and fluoroquinolone toxicity syndrome articles as well.Davidtfull (talk) 08:28, 15 February 2009 (UTC)

Patent Extensions:

A member contributed a block of text providing more details concerning pediatric patent extensions. I had revised this text for a more balance presentation as well as reworded the portion concerning Kennedy's involvment. The actions and the statement describing them (being attributed to Kennedy in the original addition) were not supported by the citation being used. Whether the sponsors were democrats or republicans I felt added nothing to the information being presented. The reference made regarding the Bush administration would be valid as this describes who was in charge when this legistlation was signed into law and who actually signed it into law. But whether Bush, or any other politician was a republican or democrat would be irrelevant as we are trying to explain what took place, who was involved, and the end result. Party affiliation adds nothing to this information. It simply adds fuel for a needless political debate regarding what party was responsible, which would violate the neutral point of view in my opinion, as this tries to cast blame on a political party rather than the person(s) actually responsible. I'm sure that if a reader had an interest regarding the political affliation(s) of those involved they would have no problem discerning this without it being pointed out to them within the article.Davidtfull (talk) 02:58, 13 February 2009 (UTC)

Major revision of this artcle

After discussing this article with a number of editors familar with the wikipedia pharmacy project I have made an effort to remove the false and misleading information found within this article, as well as restructured a major portion of the article to include verifiable information that would be considered important to the patient and treating physician alike. The previous article read more like a selective "cut and paste" from the package insert and studies promoting the indiscriminate use of this drug. More like a manufacturers madison avenue propaganda piece. I will continue to work on this article to refine it even more, as well as add more relevant information in the days and weeks to come. Any comments regarding these revisions are more than appreciated and encouraged.

This article has remained rather dormant for quite some time and the previous information is now grossly out of date or no longer relevant. As it appears that no one has really taken any interest in working on this it appears that the responsability has fallin on my shoulders. As such any help from the other editors would be geatly appreciated. I am fairly new here at wikipedia so I am still a "newbie" when it comes to such editing.

But I am far from being a "newbie" when it comes to these drugs as I have been researching and writing articles concerning these issues for well over a decade now. The reference material I have accumulated over the years fills (4) four drawer file cabinets and several hard drives, and was referenced within the petitions filed by Public Citizen as well as the Attorney General of the State of Illinois. But I am a fledging wikipedia editor who is not afraid to admit to his lack of experience working within the confines of wikipedia, as well as the use of the mark up language employed here, so there is NO doubt that I may inadvertently break some of the rules here by accident as I become more familiar with them. So rather than just delete something I may have screwed up on please bring these errors to my attention as well as suggest some kind of solution. Either here or on my talk page. This would be greatly appreciated. Thanks. Davidtfull (talk) 08:33, 4 February 2009 (UTC)

Mechanism of tendon damage?

What is the mechanism by which these drugs lead to tendon damage? ThVa (talk) 23:10, 8 July 2008 (UTC)

Public Citizen Sues FDA over CIPRO labeling - Black Box Labeling Wanted

The consumer group went to federal court today to force the agency to act on a petition filed last summer seeking stronger warnings about the risks of tendon rupture associated with fluroquinolones, a class of antibiotics used to treat bacterial infections. These includes Levaquin, a Johnson & Johnson med, and Bayer’s Cipro, along with other brand name versions and various generics. (Here is the lawsuit). See full article and copy of lawsuit at: http://www.pharmalot.com/2008/01/public-citizen-sues-fda-over-antibiotic-risks/ Although the labels warn of tendon ruptures, Public Citizen wants the FDA to place Black Box warnings on the drugs. —Preceding unsigned comment added by 71.41.19.148 (talk) 12:04, 7 February 2008 (UTC)

Major side effects of ciprofloxin hidden but often severe and permanent

My daughter had a side effect to ciprofloxin. Her main side effect (drug taken about the first of August 2007) was severe, full body pain and weakness which may become chronic. She was a student, but the pain is so great that she does not have the strength to carry her text books. The cipro was given for "food poisoning" a disorder that rarely requires any drug treatment. My research since she became ill indicates that tendon damage to the point of tendon rupture is not "rare" but much more common than Bayer would have you believe. My research showed that chronic pain may continue for years after the cipro is given, and that there is massive internal damage to all tendons and damage to the microvessels that impacts the entire body and mind. For the few patients so affected, cipro is the drug from hell. The FDA has required strong warnings on the labels and inserts warning of severe side effcts, that are so severe that people have committed suicide to stop the pain. The research of fluorquinolone drugs such as cipro shows that many drugs in this class were so toxic and produced such severe side effects that many have been taken off the market. Cipro may be the most toxic of all legal drugs, and even though it is a potent and effective antibiotic, there are many victims, including my family, that believe that the potential side effects outweigh its benefits.

There are a number of websites that have documented in layman's words these horrible side effects, which those writers have taken from original peer reviewed medical journals. Two primary sites that cover these side effects are: http://fqresearch.com , http://www.fluoroquinolones.org/ , and several others that are listed on these two sites.

Following is a list of possible side effects from cipro taken from http://www.medications.com/se/cipro : Asthenia, Edema, Fever, Malaise, Rigors, Substernal Chest Pain, Syncope, Cardiovascular Disorders, Cardiac Failure, Circulatory Failure, Hypertension, Central and Peripheral Nervous System Disorders, Abnormal Coordination, Coma, Convulsions, Seizures, Hyperkinesia, Hypertonia, Hypoaesthesia, Involuntary Muscle Contractions, Paresthesia, Paralysis, Speech Disorders, Stupor, Tremor, Vertigo, Gastrointestinal System Disorders, Dry Mouth, Dysphagia, Gastroenteritis, G.I.Hemorrhage, Pancreatitis, Pseudomembranous Colitis, Tongue Edema, Hearing and Vestibular Disorders, Ear Disorders, Tinnitus, Heart Rate and Rhythm Disorders, Arrhythmia, Atrial Fibrillation, Bradycardia, Cardiac Arrest, Heart Block, Palpitation, Supraventricular Tachycardia, Tachycardia, Ventricular Fibrillation, Hematology, Decreased Lymphocytes, Liver and Biliary System Disorders, Abnormal Hepatic Function, Cholelithiasis, Hepatic Coma, Jaundice, Metabolic and Nutritional Disorders, Aggravated Diabetes, Mellitus, Decreased Glucose, Decreased Magnesium, Increased Calcium, Dehydration, Hyperglycemia, Hyperkalemia, Hypoglycemia, Hypokalemia, Increased LDH, Weight Loss, Musculo-Skeletal System Disorders, Arthralgia, Arthritis, Arthrosis, Muscle Weakness, Myalgia, Osteromyelitis, Rhabdomyolysis, Synovitis, Tendinitis, Myo, Endo, Pericardial and Valve Disorders, Angina, Pectoris, Coronary Thrombosis, Myocardial Infarction, Neoplasms, Carcinoma, Parosmia, Platelet, Bleeding and Clotting Disorders, Abnormal Platelets, Embolism, Epistaxis, Purpura, Thrombocytopenia, Psychiatric Disorders, Abnormal Dreaming, Aggressive Reaction, Agitation, Anorexia, Anxiety, Confusion, Delirium, Depression, Emotional Liability, Hallucination, Impaired Concentration, Impotence, Manic Reaction, Mental Deficiency, Nervousness, Paranoia, Sleep Disorders, Somnolence, Withdrawal Syndrome, Suicide, Red Blood Cell Disorders, Anemia, Reproductive Disorders, Ejaculation Failure, Resistance Mechanism Disorders, Fungal Infections, Genital Moniliasis, Respiratory System Disorders, ARDS, Asthma, Coughing, Dyspnea, Haemoptysis, Hypoxia, Pleural Effusion, Respiratory Insufficiency, Respiratory Failure, Skin and Appendages Disorders, Erythema Nodosum, Genital Pruritus, Increased Sweating, Skin Disorders, Skin Exfoliation, Skin Ulceration, Urticaria, Urinary System Disorders, Abnormal Renal Function, Acute Renal Failure, Face Edema, Crystalluria, Cylindruria, Hematuria, Vascular (Extracardiac) Disorders, Cerebrovascular Disorder, Phlebitis, Vision Disorders, Abnormal Vision, Conjunctivitis, Diplopia, Retina Damage, Cornea Damage, Ophthalmologic Abnormalities, Cataracts, Multiple Punctate Lenticular Opacities, White Cell and RES Disorders, Granulocytopenia, Leukocytosis, Leukopenia, Lymphadenopathy, WBC Abnormal Count, Allergic Pneumonitis, Anaphylactic Shock, Anaphylactoid Reaction, Dysphonia, Abnormal EEG, Encephalopathy, Eosinophilia, Erythema Multiforme, Hemolytic Anemia, Multi System Organ Failure (Death), Increased International Normalized Ratio (INR) Prothrombin Time, Stevens-Johnson Syndrome, Tendon Rupture, Torsades de Pointes, Vasodilation, This is but a small sampling of various adverse reactions associated with such therapy.

This list goes on and on and on and on and on. The physician has no clue as to what these drugs can and will do to a patient. The physician will likely prescribe steriods and other drugs which often have adverse interactions with the fluoroquinone drugs, sometimes resulting in unexpect outcomes such as death.

There is no known treatment for a majority of the severe reactions. Such reactions often DO NOT abate once therapy is discontinued in a subset of those so treated and the current research indicates that such events are to be considered permanent in nature.

Perhaps the wide range of actions and side effects is due to the ability of flourine in Cipro to substitute for hydrogen due to their very similar van der Waals radiuses. For a list and review of the role of flourine in drugs, see: http://www.halocarbon.com/halocarbon_media/swinson_109.pdf Obviously, this is an extremely basic change in our biochemistry!

Consequently, people should not use cipro or any of the fluoroquinone class of antibiotics without consideration of the risk of permanent adverse health as an outcome posibility. Physicians should prescribe these drugs only in cases of life threatening disease and then only as a third line of treatment after other drugs have failed. The patient must be informed that these side effects are not rare and that they can be life long in duration.

To the editors, may I post a short version of this on the main article? georgeeby 8/17/2007

Please read the section below, specifically the comments regarding how side effects are presented in the article. The websites you cite above are, unfortunately, not reliable sources. I am truly sorry for your daughter's experience, but I can't see how adding an indiscriminate list of all possible side effects is productive. I agree this article is currently unbalanced and quite lacking in information, but we must be careful not to simply shift bias instead of making it impartial. Fvasconcellos (t·c) 02:02, 19 August 2007 (UTC)

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Perhaps you will acknowledge the "neutrality" of Walgreens Drug Store "CAUTIONS" and "SIDE EFFECTS", which are found in their article http://www.walgreens.com/library/finddrug/druginfo1.jsp?particularDrug=Cipro&id=9387 which read as follows:

<redacted, copyrighted text>

Perhaps my arguement is with the word "rarely" when descibing severe side effects. I do not know very many people well enough to discuss their health issues, but in mentioning my daughter's plight to my friends, I found that: (1) my own physician suffers from tendon issues and chronic pain from using cipro, (2) a nurse of a prominent research scientist in Detroit has the same issues that she attributes to cipro, (3) I too have unexplained shoulder pains which started several months after taking cipro, and a friend has had chronic pain and weakness for about 6 years after taking cipro during breast surgery.

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I believe that the unreliable sources that you critisize may be right, in that these severe side effects are less "rare" than the totally unbiased, extremely reliable, highly scientific and undisputable reports of Bayer and the U.S. FDA would have one believe. What does the FDA say about cipro?

From the http://www.medscape.com/viewarticle/491176 page are these words about what the FDA says:

Moxifloxacin (Avelox) and Ciprofloxacin (Cipro) Linked to Peripheral Neuropathy and Tendon Effects

On July 14 and July 28, the FDA approved changes to the safety labeling for moxifloxacin hydrochloride tablets and moxifloxacin hydrochloride in sodium chloride injection (Avelox, Avelox IV, made by Bayer Pharmaceuticals) and ciprofloxacin hydrochloride tablets and oral suspension (Cipro, made by Bayer Pharmaceuticals), warning of the risks of peripheral neuropathy and tendon effects associated with their use.

The FDA has received rare postmarketing reports of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons and resulting in paresthesias, hypoesthesias, dysesthesias, and weakness in patients receiving quinolone therapy.

Ruptures of the shoulder, hand, Achilles tendon, and other tendons resulting in prolonged disability or requiring surgical repair have also been reported in patients receiving quinolone therapy, including moxifloxacin and ciprofloxacin.

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Again, my arguement is with the notion that these severe side effects are "rare". The problem appears to be that the testing of side effects from the cipro class of drugs did not extend far enough in time after treatment was stopped. Classically, side effects occur during treatment, not 6 to 12 months afterwards. In the case of Cipro, the damage to tendons and nerves seems irreversible and these side effects seem to occur (start) up to a year after treatment is stopped (from what I have read in the "unreliable" reports above), which actually are layman's condensations of about 400 original medical research reports found on http://pubmed.gov , which is a primary research resource fom many physicians and the educatable public.

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I am one of those "permanently poisoned by cipro" individuals. The permanent side effects are real. If these rare side effects hit you, your life is destroyed. Since I took a week of Cipro in 2006, I have permanent tinnitus, tendonitis, insomnia, anxiety, severe depression (loss of emotion), psychosis, other sensory disturbances, constipation, the list goes on, like the list of side effects on the warning labels... Rare permanent side effects for most individuals, maybe. None of these "side effects" have been treated or remediated by any of my physicians. The list of side effects given to patients should make clear than any or all could become permanent. I am expecting tendon ruptures in the future. The FDA should analyze the data it has via Medwatch and follow Public Citizen's reminder to publish the widely recognized tendon issues in a Black Box and send "Dear Doctor Letters" to let physicians know how toxic this drug is.

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—Preceding unsigned comment added by 68.199.93.11 (talk) 03:12, 22 February 2008 (UTC)

How about the "ask a patient" website? Think they are biased? For many comments about cipro serious side effects including death, see http://www.askapatient.com/viewratings.asp?drug=19537&name=cipro&sort=age They have no axe to grind, and they simply offer the reports of many people. With the internet, the drug companies will be exposed for the side effects their drugs produce and the efficaciousnous or lack thereof of their products.

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The Weston A. Price foundation at http://www.westonaprice.org/healthissues/cipro.html has what they report to be "The True Story of Cipro", which offers a fascinating review of the drug's history. Further, they report in part: "Achilles tendon rupture was shown to occur even after withdrawal of the drug with examination showing pathological ultrastructure alteration in tendinocytes. Just as in other cases of fluoride poisoning, studies in animals show that magnesium deficiency aggravates the induced tendinopathy.14,19

"Fatal Drug Interactions Just as with Baycol (NOTE: This drug was recalled by the FDA), drug interactions with ciprofloxacin have resulted in fatal outcomes due to potentiation of another drug’s effects including theophylline,4,20 methadone21 and warfarin.22"

"Just like Baycol and other fluorinated drugs, ciprofloxacin is a potent inhibitor of the thyroid hormone-regulated P 450 enzyme system in the liver. Of all fluoroquinolones, ciprofloxacin and enoxacin have shown the greatest inhibitory capacity.4"

"P450 IA2 prevents the metabolism and inactivation of methylxanthines, thereby causing increased serum concentrations of drugs like theophylline (found in tea) and caffeine (found in coffee and soft drinks), which in turn causes excess central nervous system and cardiac stimulation. As mentioned above, Cipro also elevates serum fluoride levels."

"The liver has been identified as a target organ of fluoroquinolone toxicity in animal studies.23 As early as the 1930s, scientists at Bayer and Knoll had discovered that all organic fluoride compounds tested (including those used for fluoroquinolone production) interfered with thyroid hormone activity in liver and muscle tissue. Meanwhile, they also showed "anti-bacterial" activity. This led to the development of many fluorinated medications, including the numerous compounds then used very successfully in the treatment of hyperthyroidism.24,25 A Dr. Kraft of the Knoll corporation invented many fluorinated "medications." When it was discovered that some of these organic compounds had the same detrimental effects on teeth and bone as inorganic fluoride (although much less actual F ion was involved) he even filed patents on behalf of Knoll for use of these compounds in dental preparations.26,27"

"pregnant women should never take ciprofloxacin. Cipro transfers through the placenta. It inhibits P450 1A2 which has been shown to be critical for neonatal survival as it influences the physiology of respiration in neonates. Mice lacking this cytochrome died shortly after birth and showed symptoms of severe respiratory distress.28 Respiratory distress is also a side-effect of ciprofloxacin in adults.9 Cipro also transfers through breastmilk."

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An important point here (outside my family's disaster) is that drug side effects are damaging our trust in medicine and pharmaceuticals. We should not be required to voluntarily play "Russian Roulette" every time we go to our doctor for a tummy ache.

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Here is the letter that the FDA sent out about Cipro found on the http://www.fluoroquinolones.org/ site , which is a depository of all things "cipro"

NDA 19-537/S-053, S-054 NDA 20-780/S-017, S-018 Bayer Corporation Pharmaceutical Division Attention: Andrew S. Verderame Director, Regulatory Affairs 400 Morgan Lane West Haven, CT 06516-4175

Dear Mr. Verderame:

Please refer to your supplemental new drug applications, which were submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for the following: NDA # Drug Product Supplement Number Letter Date Receipt Date S-053 April 7, 2004 April 9, 2004 19-537 Cipro  (ciprofloxacin hydrochloride) Tablets, 100 mg, 250 mg, 500 mg, 750mg S-054 April 7, 2004 April 9, 2004 S-017 April 7, 2004 April 9, 2004 20-780 Cipro  (ciprofloxacin) Oral Suspension, 5% and 10% S-018 April 7, 2004 April 9, 2004 NDA 19-537/S-053 (tablets) and NDA 20-780/S-017 (oral solution) were submitted as Changes Being Effected (CBE) and provide for additional safety information in the label. Revisions are included in the PRECAUTIONS, Drug Interactions subsection of the package insert. NDA 19-537/SLR-054 (tablets) and NDA 20-780/SLR-018 (oral solution) were submitted as CBE and provide for the addition of quinolone class labeling in the WARNINGS section, PRECAUTIONS, Information for Patients subsection and ADVERSE REACTIONS, Post-Marketing Adverse Events subsection as was requested in the supplement request letter on November 26, 2003 and the facsimile from the Division dated March 10, 2004. These supplements provide for the following changes to the Cipro  Tablet and Oral Suspension label. Deleted text is noted by strikethrough and added text is noted by double underline:

1. The following revisions were made under the WARNINGS section: Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.

Tendon Rupture: Effects: Ruptures of the shoulder, hand, and Achilles and other tendon ruptures tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including ciprofloxacin. Post-marketing surveillance reports indicate that the this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. Ciprofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including ciprofloxacin.

2. The following bullet was added to the PRECAUTIONS, Information for Patients subsection:• that peripheral neuropathies have been associated with ciprofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, they should discontinue treatment and contact their physicians.

3. The following revisions were made under the PRECAUTIONS, Drug Interactions subsection: Non-steroidal anti-inflammatory Animal studies have shown that the drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies.

4. The following revisions were made under the ADVERSE REACTIONS, Post-Marketing Adverse Events subsection: Post-Marketing Adverse Events: The following adverse events have been reported from worldwide marketing experience with quinolones, including ciprofloxacin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, or (3) strength of causal connection to the drug. Agitation, agranulocytosis, albuminuria, anaphylactic reactions, anosmia, candiduria, cholesterol elevation (serum), confusion, constipation, delirium, dyspepsia, dysphagia, erythema multiforme, exfoliative dermatitis, fixed eruption, flatulence, glucose elevation (blood), hemolytic anemia, hepatic failure, hepatic necrosis, hyperesthesia, hypertonia, hypesthesia, hypotension (postural), jaundice, marrow depression (life threatening), methemoglobinemia, monoliasis moniliasis (oral, gastrointestinal, vaginal), myalgia, myasthenia, myasthenia gravis (possible exacerbation), myoclonus, nystagmus, pancreatitis, pancytopenia (life threatening or fatal outcome), peripheral neuropathy, phenytoin alteration (serum), potassium elevation (serum), prothrombin time prolongation or decrease, pseudomembranous colitis (The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.), psychosis (toxic), renal calculi, serum sickness like reaction, Stevens-Johnson syndrome, taste loss, tendonitis, tendon rupture, torsades de pointes, toxic epidermal necrolysis, triglyceride elevation (serum), twitching, vaginal candidiasis, and vasculitis. (See PRECAUTIONS.)

We completed our review of these applications and they are approved effective on the date of this letter. The final printed labeling (FPL) must be identical to the enclosed draft labeling (text for the package insert submitted April 7, 2004). The electronic labeling rule published December 11, 2003, (68 FR 69009) requires submission of labeling content in electronic format effective June 8, 2004. For additional information, consult the following guidances for industry regarding electronic submissions: Providing Regulatory Submissions in Electronic Format - NDAs (January 1999) and Providing Regulatory Submissions in Electronic Format – Content of Labeling (February 2004). The guidances specify that labeling is to be submitted in pdf format. To assist in our review, we request that labeling also be submitted in MS Word format. If formatted copies of all labeling pieces (i.e., package insert, patient package insert, container labels, and carton labels) are submitted electronically, labeling does not need to be submitted in paper. For administrative purposes, these submissions should be designated "FPL for approved supplements NDA 19-537/S-053, S-054 and NDA 20-780/S-017, S-018." Approval of these submissions by FDA is not required before the labeling is used.

If you issue a letter communicating important information about these drug products (i.e., a “Dear Health Care Professional” letter), we request that you submit a copy of the letter to each NDA and a copy to the following address: MEDWATCH, HFD-410 FDA 5600 Fishers Lane Rockville, MD 20857 We remind you that you must comply with the requirements for an approved NDA set forth under 21 CFR 314.80 and 314.81. NDA 19-537/ S-053, S-054 NDA 20-780/S-017, S-018 Page 4 If you have any questions, call Robin Anderson, R.N., M.B.A, Labeling Reviewer, at (301) 827-2127. Sincerely, {See appended electronic signature page} Renata Albrecht, M.D. Director Division of Special Pathogen and Immunologic Drug Products Office of Drug Evaluation IV Center for Drug Evaluation and Research

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The FDA knows these facts, but patients may not be warned that the side effects of this class of drugs may be worse than the symptoms they are intended to treat. Elsewhere you will find that these drugs are to be a "third line" of defense, to be used after failure of other antibiotics. Yet, in my daughter's case of a "food posioning" event, cipro was given as a "first choice" drug with absolutely no mention of these severe side effects. I suspect that had she been warned properly, she would have used a safer alternative.

I SUGGEST RECALL CIPRO JUST LIKE BAYCOL!

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There are many other flourine-containing drugs that produce adverse side effects, some in good proportion to their benefits and others with poorer risk benefits. The list includes: 5-fluorouracil (anticancer), flunitrazepam (Rohypnol) (the date rape drug) and nitrazepam (Mogadon) tranquilizers, fluoxetine (Prozac) and paroxetine (Seroxat/Paxil) antidepressants, the entire class of the fluoroquinolones antibiotics, fluconazole (Diflucan) and flutrimazole (Micetal) the antifungals, Mefloquine Lariam) the antiprotozoal, (diethylamido)sulfur trifluoride DAST, atorvastatin calcium (Lipitor) the anti-cholesterol agent, a variety of flourinated toothpastes and many more, best found through specific web searchs (with flourine).

Georgeeby 11:22, 20 August 2007 (UTC)

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The article certainly needs to be expanded, particularly regarding side effects, but we can't add anecdotal reports (such as those from askapatient.com) to the article or use them as references. Again, if there is information regarding these effects which can be cited to a reliable source and written in an impartial manner (and I'm sure there is) there is no reason why it shouldn't be added. If you'd like to expand the article to this effect, please do. I'll just ask you to have a look at Wikipedia:Verifiability and Wikipedia:Neutral point of view, and don't take it personally if your edits are reverted: just come back to the Talk page and discuss. Fvasconcellos (t·c) 20:51, 19 August 2007 (UTC)

By the way, I've removed the Walgreens text you quoted above, not because it was unreliable—no need for scare quotes here—but simply because that was quite a hefty amount of copyrighted content. If I can help you or you have any questions, please feel free to contact me or leave them here. You may also want to get in touch with our Clinical medicine and Pharmacology projects; the editors at either can provide input or answer questions regarding additions to the article, what kinds of sources are appropriate etc. Best, Fvasconcellos (t·c) 20:51, 19 August 2007 (UTC)

2004-2005 Ciprofloxacin talk

Also implicated in the rise of resistant bacteria is the use of lower-cost, less potent fluoroquinones, and the widespread addition of Cipro and other antibiotics to the feed of farm animals, which leads to greater and more rapid weight gain, for reasons which are not clear.

the word sould be fluoroquinolones, or is it correct?

quinolones JFW | T@lk 08:45, 21 Nov 2004 (UTC)

The relative safety of Fluoroquinolones? These drugs can cause kidney damage, liver damage, neurological problems, weakened cartilidge...

It seems like this was written by a shill for the drug companies. I've taken drugs penicillin type drugs and I've taken a course of Cipro (for orchitis.) Cipro was much much harsher.

--Wiserd 8 July 2005 20:02 (UTC)

But will you concede that your personal experience may not reflect statistical reality? Allergies are much rarer, and the side-effects you kindly inserted are rarer e.g. than those in macrolides (stomach upset, transient hearing loss). This was not written by a "shill for the drug companies". The side-effects are not mentioned because thankfully they are rarer than therapeutic successes. I reckon your orchitis improved. JFW | T@lk 12:08, 10 July 2005 (UTC)

I'm not convinced the cipro was 100% successful in my case, though residual symptoms may be due to trauma\autoimmune response\some other non-bacterial factor. I'm going to head back to the Doctor as soon as I have time. But certainly my personal experience is far from a controlled study.

My language was a bit harsh. The use of cipro certainly outweighs the side effects in certain instances. But you have a lot of people self-administering cipro such as with the anthrax scare, overproscription, etc. and doing a great deal of harm to themselves, outside of the normal issues of antibiotic resistance.

The article on Cipro came across as a bit unbalanced, defending Bayer, praising cipro and offering no list of side effects or warnings. I suppose the Macrolides you mentioned don't have a list of side effects either (I just looked up their formatting now) though the tetracyclines, which I was going off of, did.

--Wiserd 23:33, 10 July 2005 (UTC)

I totally agree that people should not be self-administering any prescription drugs, and I think due to selective resistance this is especially important in antibiotics, as it harms more people than just the "patient".

I have condensed the side-effect area a bit. One has to be jolly careful with the reporting of side-effects in the medical literature. Often one or two cases of a side-effect are described, and in many instances the link is really really tentative (e.g. they were also taking other drugs at the same time).

I've also changed the links to the PubMed abstracts into actual academic references. Unfortunately the Brouwers article was not accessible as fulltext, and I've had to time to check which CYP450 isoenzyme is inhibited by cipro. JFW | T@lk 11:51, 11 July 2005 (UTC)

Thanks for tightening\cleaning things up. Very nice summation. I do think the neurological problems, particularly insomnia, feelings of dread, and some other more serious problems are genuine characteristics of ciprofloxacin since they seem to be characteristics of most fluoroquinolones. Significant phototoxicity is also a characteristic of most fluoroquinolones, though ciprofloxacin seems to be mild in this regard relative to others in its class.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15738624&query_hl=23 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12740182&query_hl=23

Likewise, the fluoroquinolones are generally chondrotoxic as well as weakening tendons, and this can be demonstrated in vivo in rats.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15456526&query_hl=21 http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12052667&query_hl=2

"and I've had to time to check which CYP450 isoenzyme is inhibited by cipro."

"Likewise, quinolone antibiotics such as ciprofloxacin inhibit the metabolism of CYP1A2 substrates."

from - http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15058617&query_hl=36

--Wiserd 12:31, 12 July 2005 (UTC)

Better: please see PMID 1510417. PMID 12052667 is a good review, but one of us may need to read the fulltext to see what is worth mentioning. I don't think we should extensively mention animal studies. The Japanese study is not a good choice - most readers do not understand Japanese :0(. JFW | T@lk 13:49, 12 July 2005 (UTC)

Hai. Nihongo ga wakarimasen, ne. (Translation, " I don't understand Japanese")

--210.213.157.108 15:13, 2 August 2005 (UTC)

Action against Enterococcus?

According to their website: http://www.ciproxr.com/PAT/Patient_index.asp Cipro XR is active against Enterococcus faecalis, but this Wiki entry contradicts this. Which is right?

Cipro resistance is increasing. JFW | T@lk 02:43, 14 October 2005 (UTC)

I think it's only an incomplete list. You can see it:Ciprofloxacina. --F. Cosoleto 00:12, 15 October 2005 (UTC)

I'm having serious problems with Enterococcus faecalis which I fought well with Medocyprin drug that uses Ciprofloxacin as main base. Problem is, that I've undertaken 2 treatments, but infection always came again. Now I'm in different country, fighting same problem again, 10 years to the date :) People don't give up! —Preceding unsigned comment added by 172.188.177.114 (talk) 12:18, 30 September 2007 (UTC)

"Unfortunately?"

Removing that from the line that read "Unfortunately, Bayer took a financial blow..." Not that it's not a heartbreaker or anything.

I agree that it was not NPOV, but your sarcasm is misplaced. Bayer responded to a demand, which was a shrewd business decision which appears to be legitimate in any other branch of business apart from pharmaceuticals. JFW | T@lk 18:24, 31 January 2006 (UTC)

And a qualification: the business decision turned out to have been a bad one. JFW | T@lk 18:25, 31 January 2006 (UTC)

"Unfortunately" is correct, but in another sense. It is really unfortunate how two-faced the USA proved themselves once again when the US government ruled out Bayer's patent after these presumed anthrax terror attacks (only one of which turned out to be real, and that one wasn't a terror attack) under the term "public health interest".

It is remarkable that a number of US companies hold and viciously defend (with aid from their government) the patents for nearly every significant treatment of AIDS. There is no consideration whatsoever that AIDS might possibly be an issue in regions like central Africa. Of course it's Africa, not the USA, and those people are not only black, they are also poor. Really, who cares if they can't afford treatement, and if a few million of them die. —Preceding unsigned comment added by 91.35.163.79 (talk) 07:53, 6 March 2008 (UTC)

Contradiction

The DNA gyrase article says gyrase is only found in bacteria, while this article says it's found in both but it acts more on bacterial. Which is correct? --zandperl 19:23, 26 April 2006 (UTC)

just bacteria. Well prokaryotes to be more accurate. I don't see where this is in the article though. SenorKristobbal 11:47, 9 November 2006 (UTC)

DNA gyrase is an enzyme used in DNA supercoiling in prokaryotic cells (bacteria), but not eukaryotic cells (including mammal cells). However, the mitochondria which supply energy for mammalian cells do use DNA gyrase, therefore one speculated mechanism of fluoroquinolone toxicity is that it destroys the mitochondria in mammalian cells which in turn causes the cells to malfunction and/or die. —Preceding unsigned comment added by 68.6.124.217 (talk) 18:19, 13 June 2009 (UTC)

cipro and quercetin

This article may discuss the interaction between Cipro and quercetin. I can only get the abstract, which gives results but not specific antibiotics used. [1] There seems to be a very minor but positive interaction between the two.

Some other cipro / fluoroquinolone issues

I am currently researching cipro for treatment of a pneumococcus (streptococcus pneumoniae) infection for a loved one. Spent a lot of time reading original research articles in refereed journals. Some issues I'm wondering if you all would think are worth adding:

• Central Nervous System (CNS) side effects: There are reported psychotic reactions (hallucinations, paranoia. The research I found indicated these are all temporary events that go away quickly upon cessation of treatment. But does seem important to know about.
• Interaction with NSAID: Should this be moved and / or repeated in the "interactions" section and not just "contraindications" section? Also, should ibuprofen be specifically mentioned?
• Fluoroquinolones for streptococcus pneumoniae infections: While ciprofloxacin is not idea for raging strep pneumo infections, it may be appropriate for "mop up" after treatment with vancomycin. Important parameters are MIC levels and drug uptake. There are good reports out there showing that some 3rd generation fluorquinolone may be have much higher efficacy against strep pneumo than cipro. For example moxifloxacin may be 20 times more effective (I am not sure of the technical way of defining "efficacy").
• Arthropathic side effects in children: I found some good articles that (a) demonstrate undetectable risk in pediatric usage and (b) explanations for why human side effects are much dimished compared with puppy or bunny models.

Let me know if you think these would be good additions to the article. I did spend quite a bit of time doing my own research while in the hosptial at nights. (I am a very new wiki user, so you may want to send me an email with your thoughts, I am not sure how I will notice updates to this page.) I will also look to update information I found on vancomycin and side effects. Skoch3 14:14, 21 December 2006 (UTC)

Business aspects

I've tagged the whole "Business aspects" section for a neutrality check. It is completely uncited, and statements such as "with the other drugs developed by other pharmaceutical companies relegated to 'me-too' status and forced to compete on the basis of lower cost" are not at all encyclopedic. I'll see if I can get to this later. Fvasconcellos (t·c) 04:00, 3 June 2007 (UTC)

This might help http://www.managingip.com/?ISS=13068&PUBID=198&Page=9&SID=486721&SM=&SearchStr= ? Dnadiver

I removed the section - as you say it's completely uncited and has been tagged for over a year. 75.45.130.80 (talk) 11:39, 26 October 2008 (UTC)

Information lacking citation

Ciprofloxin can cause neurological agaitation in health young adults. A State toxicology report indicates that ciprofloxin caused a toxic reaction, grand maul seizure, permanent loss of conciousness and subsequent death in a 28 year old in North Alabama in 1992.

I cut this paragraph Snafflekid 22:40, 7 August 2007 (UTC) 172.188.177.114 12:21, 30 September 2007 (UTC)

Band named Ciprofloxacin

I've removed the section about the band from this article, which is about the drug. If notoriety standards warrant it, that information should be in a separate article about the band. —Preceding unsigned comment added by 66.75.245.214 (talk) 03:05, 28 August 2008 (UTC)

vomiting

it causes frequent vomiting in pregnant lady. —Preceding unsigned comment added by 202.79.40.132 (talk) 12:07, 16 April 2009 (UTC)

nausea

in my home, my bro took this medicine, he noticed nausea. —Preceding unsigned comment added by 202.79.40.132 (talk) 12:09, 16 April 2009 (UTC)

"Multiskeletal" system

Is this supposed to be "musculoskeletal"? Or is it something else entirely? Samer (talk) 16:35, 3 May 2009 (UTC)

As one only has one skeleton I would think that it should be musculoskeletal.--Literaturegeek | T@1k? 22:17, 3 May 2009 (UTC)

Both forms are used within the literature, with multiskeletal being specific and musculoskeletal being more of a general term, i.e.:

"Early studies in the 1970 showed that disuse of the multiskeletal system influences the growth and stability of bones. In that connection, Uthoff et al. performed experiments, comparing normally used and disused bones of young and old dogs. They found that a disuse of bone destabilize it, and changes the morphology, resulting in a loss of bone mass (Uhthoff and Jaworski 1978)."

"Musculoskeletal is a general term which is defined as relating to muscles and the skeleton.

Thus, the musculoskeletal system involves the muscles, bones, joints (the place of union between two or more bones), bursa (fluid sac between the muscles and bones that forms in areas of friction), ligaments (a fibrous band of tissue connecting bones)and tendons (a fibrous band of tissue connecting muscle with bone)."

In the context we are using this term, "Musculoskeletal" appears to be a better fit than "Multiskeletal" as it is more descreptive and encompasses the bones, muscles, tendons and ligaments. I have revised the article accordingly.Davidtfull (talk) 03:31, 4 May 2009 (UTC)

trade names

It had been stated that: there is a long-standing saying in Wikipedia (it may even be codified somewhere) that "redirects are cheap". Therefore it had been suggested that: redirects for trade names are a more appropriate solution than in-article "laundry" lists, because 1) they avoid clutter in the article body, 2) they prevent issues such as an ever-growing list that may be "expanded" with inaccurate information and 3) they make it much easier for someone looking for a particular generic formulation of the drug to get to the actual article. Since this suggestion is both practical and logical I have removed the list of trade names and used redirects instead. As such someone searching Wikipedia using a brand name would simply be taken directly to the levaquin article.

I would now ask that editors not expand the trade name list, but create redirects instead. Those not familiar with this process may find the following article helpful:

http://en.wikipedia.org/wiki/Wikipedia:Redirect

Davidtfull (talk) 00:47, 19 May 2009 (UTC)

FDA and broken links

The FDA has moved ALL of the DATA that had been referenced within this article that used to reside on the FDA site. I have searched the FDA site and have updated the references accordingly. But a number of these documents appear to have been deleted by the FDA. Most of the documents that the FDA had deleted are still available on my server. In those instances where the FDA had deleted the data from the FDA site I have referenced back to the originals found on my server. I have checked all of the links within the references for this article and they all appear to be valid links at this time (7-4-2009).

(removed previous opinion regarding this once the following information became known to me)

I guess this is the cause of these broken links:

Launch of New FDA Website Makes Some Older Links Nonfunctional The FDA’s recently announced overhaul of its website took effect last week, and the immediate result was a short-term increase in inconvenience as users scrambled to find web page addresses that had changed. Some hyperlinks posted after the launch of the site June 1 pointed to web addresses that are no longer valid. “As we have just rolled out the new website and have become aware of some initial problems with broken links, etc., we are working diligently to address these matters,” FDA spokeswoman Crystal Rice said, adding that she is not aware of a specific timeline for resolving the issues.

Davidtfull (talk) 06:01, 3 July 2009 (UTC)

Licensed usages

There are a number of statements in this section that are general criticisms against the use of antibiotics for various medical conditions. These statements are imprecise and poorly referenced. Also, they are not specific to ciprofloxacin, so they do not belong here. They should either be removed, or fixed and then moved either to Antibiotics or to the pages for each specific medical condition.

Because of the sloppy and poorly thought-out style of these statements, they appear to be merely an attempt to slant the POV of the article against the use of antibiotics. That is another reason why they should either be fixed or removed, they violate NPOV.

For example, there was this statement about sinusitis: "Antibiotics such as ciprofloxacin do not improve sinusitis symptoms." with a totally garbled reference that seemed to be a mixture of two references. After a some search work, I found what seems to be one of the intended references in "The Lancet", so I fixed it. I still can't figure out what the other part of the reference was supposed to be, so I left it as is. Now, the statement is just false - antibiotics are often an effective and essential treatment of sinusitis, but not always. There is research about that, but the reference has nothing to do with it - it is about long-term clinical outcome. I corrected the statement to better reflect the reference, and I copied this information to Sinusitis where it belongs.

I did not delete anything yet - I hope someone will work on more of these, fix them, and move them to where they belong. But if not, they should all be just deleted.

Perhaps instead there should be a general disclaimer something like: While ciprofloxacin is licensed for use for these conditions, it is not necessarily a recommended treatment; see the linked article for each condition.

There does seem to be a problem of overuse of this drug; that should be described here very specifically, with references. But general diatribes against antibiotics do not belong here. StormWillLaugh (talk) 10:57, 26 July 2009 (UTC)

The garbled reference you are referring to was the result of a statement being removed and a fragment of the associated reference being left behind. I have deleted it from this article. I think this is also present in the other articles that used the same references, if so it can be safely deleted there as well as it is just an artifact. Davidtfull (talk) 05:30, 31 July 2009 (UTC)

Drug of last resort

"drug of last resort" should be removed from this article; at best if it was better sourced it would have to be something like "recommended by ____ ". The attached sourcing mentions quinolones in passing, and doesn't address cipro in particular, and advocates reclassifying for wider use. Even if it did back up the claim for cipro to be a drug of last resort (rather than quinolones having been considered such in the past) it would need to be backed up by much stronger sources than a passing mention in a committee meeting. Fuzbaby (talk) 22:05, 27 July 2009 (UTC)

Indeed. Even if it were still considered a drug of last resort, it certainly isn't used as such. Fvasconcellos (t·c) 23:33, 27 July 2009 (UTC)

I also having issue with the risk/benefit section. Besides being something that is individual to each patient (and not necessarily something for an encylcopedia) it is smattered with claims about cipro's use that are not supported by the given references. It also has vague or patently false claims (see part about c diff, which apply to almost any antibiotic, and part saying cipro should never be a first given drug in any situation) I've half a mind to remove the entire section, but I'm hopeful it can undergo a major improvement instead. Fuzbaby (talk) 01:14, 29 July 2009 (UTC)

I added the data on C Difficile. Why is it false? You are right that C Difficile can occur with almost any antibiotic but it is much more common with quinolones and clindamycin than other antibiotics. Clindamycin is often recommended against and is not generally a first line antibiotic because of its high incidence of C Difficile. The risk of C difficile is not the same for each antibiotic or antibiotic class. Certain pharmacological factors determine whether an antibiotic has a high rate of C Difficile infection associated with it such as how much of it enters the bowel as well as its spectrum of activity against dominant gut mircobes. It is also cited and also the local hospital where I live has a policy against quinolones (because of high incidence of C Difficile infections) and as a result they are rarely used now.--Literaturegeek | T@1k? 14:47, 30 July 2009 (UTC)

Hmm...where I'm at cipro is commonly used for infectious gastroenteritis and UTIs(among other things), and I've yet to see a case of c diff from it. The two that are commonly associated with C diff is clindamycin (which you mentioned) and ampicillin/amoxicillin. However, since you bring it up I'll try to see if I can find a rate for cipro c diff in the literature. Just by a first read it kind of sounds to me like the article is claiming it is common, which it is not (although, maybe it just isn't at the dosages we use). Mostly though I take issue with the other content, that cipro should never be used as a first line drug. As a somewhat amusing side note, I've seen T-shirts made by medical volunteer groups that say "have cipro, will travel". Fuzbaby (talk) 22:43, 30 July 2009 (UTC)

Fluoroquinolones are more likely to cause C Difficile than clindamycin.See this abstract Quinolones are the number one cause of C Difficile infections. C Difficile is not a common disorder in the sense that 1 in 20 people or something drop down with C Difficile infections, but it is a serious and life threatening adverse effect which is much less likely to occur with other antibiotic classes. This is why many hospitals in the UK are bringing out policies restricting use of fluoroquinolones. They did the same with clindamycin which is actually safer as far as C Difficile goes and now fluoroquinolones are starting to go down the same path as clindamycin as falling out of favour with doctors due to C Difficile at least in the UK and Europe, probably other countries as well. I think that we need a T-Shirt "have an alternative to cipro, will travel" Hehe. :)--Literaturegeek | T@1k? 00:49, 1 August 2009 (UTC)

The never used first line may be going a bit too far as antibiotic choice often depends on severity of infection as well as sensitivity and severity of infection which can also differ from region to region and country to country. I know quinolones are typically used second or third line in UTI's over here, if say trimethoprim or augmentin or another antibiotic fails. Of course these is as always a difference between guidelines, expert opinion and prescribing behaviour of doctors.--Literaturegeek | T@1k? 01:05, 1 August 2009 (UTC)

I have no idea what fuzbaby is referring to here when he stated "Mostly though I take issue with the other content, that cipro should never be used as a first line drug." There is no content that states that cipro should never be used as a first line drug. The content, backed by appropraite references, states that for the most part, if one was to apply a realistic risk/benefit, that there would be only a few instances where the benefits outweighed the risk. There are but only one or two instances where cipro is even listed as a first line agent anyhow. So this is making yet another mountain out of a molehill.

And indeed the claims being made regarding the efficacy of cipro are supported by the references, so again I fail to see why fuzbaby would state that "it is smattered with claims about cipro's use that are not supported by the given references".

For example the first claim made is that using the quinolones (including cipro) to treat chest infections is believed to lead to bacterial resistance and render them useless for this indication. Which indeed is happening. One report states that "ciprofloxacin is not usually considered a first-line treatment for respiratory infections..."

The second claim made was that the treating physician continue to ignore this and use the quinolones inappropriately anyhow.

The next claim made is that most cases of bronchitis are caused by a viral infection and are "self-limited". Which again is a true statement. Researchers have found that using cipro to treat bronchitis is both unnecessary and risky. Within one report it was stated that "There was no statistically significant difference in outcome rates between ciprofloxacin or moxifloxacin and clarithromycin" when used to treat bronchitis.

The fact that cipro is pretty much useless for treating prostatitis is supported by two specific references that addressed cipro by name. All of the above statements are true statements. As with any reference stronger reference can always be found. So if fuzbaby thinks these references are too weak, then rather than complain about them he should find stronger ones. And as LG had already addressed the claims regarding C dif are indeed true, and not "vague or patently false claims" as fuzbaby had claimed. In fact none of the statements found under this section are to be considered false or vaque.

The research supports the fact that cipro should not be used to treat respiratory infections, chronic bacterial prostatitis, uncomplicated cervical and urethra gonorrhea or infectious diarrhea frivously. The risk may very well outweigh the percieved benefits.

Never the less I would prefer that we simply delete this whole section as it will constantly be under attack by folks such as fuzbaby no matter how strong the references used may be. You cannot cite to the fact that a drug is pretty much useless for an approved indication without causing an uproar. Best to just avoid all this grief compeletely.Davidtfull (talk) 23:38, 1 August 2009 (UTC)

You are considering deleting which section?--Literaturegeek | T@1k? 00:18, 2 August 2009 (UTC)

I was suggesting removing the risk/benefit section from the articles.Davidtfull (talk) 01:16, 8 August 2009 (UTC)

I don't have time at the moment to respond (or read everything here), but at a glance this "how strong the references used may be" is a glaring misstatement, and is the problem that several have had with some of the references, that they are exceedingly week or tangential compared to the standard references we use in practice and research. Fuzbaby (talk) 03:59, 2 August 2009 (UTC)

Interaction with NSAIDs

This follows a discussion on my user Talk page. The article is improving significantly, and Literaturegeek has been instrumental in that, but I still have a couple of concerns about the coverage of quinolone-NSAID interaction. Though I could continue the discussion on my talk page, I thought it would be better to summarize and then continue here, to preserve the link between page and discussion, and to involve any editors with an interest. I am not relocating to here due to any perception of resistance on the other editor's part.

1. I agree with the first sentence of the paragraph in question: "The Committee on the Safety of Medicines warns that the seizure risk is increased when NSAIDs are combined with quinolones", and it cites the British National Formulary. I do wonder whether this sentence would suffice.
2. This sentence: "Some regulatory bodies regard the use of non-steroidal anti-inflammatory drugs (NSAIDs) as contra-indicated and others recommend special caution and monitoring due to the risk of enhanced CNS toxicity, including increased risk of seizures" cites a Japanese Journal of Chemotherapy primary source that presents results of a survey of two hospitals in Japan. Perhaps LG is still sourcing this - I just thought others could help, or we may find that it's worded too strongly for the available sources. If not strongly supported, I would support removal.
3. This sentence: "This potentially serious interaction is the result of increased antagonism of GABA neurotransmission" that sounds definitive even though the mechanism seems uncertain, e.g. this more recent report: PMID 9347323.

Quinolones and NSAIDs are widely-used, this is a potentially significant interaction, and this section should reflect best evidence. -- Scray (talk) 23:44, 12 December 2009 (UTC)

Regarding #2, the 2001 reference PMID 11172695 is a big improvement, and it specifically states: "In recent years extensive in vivo and in vitro experiments have been performed in an attempt to explain the neurotoxic effects of quinolones sometimes observed under therapeutic conditions. However, the molecular target or receptor for such effects is still not exactly known." For this reason, I suggest removal of the mechanistic speculation. -- Scray (talk) 00:44, 13 December 2009 (UTC)

Thank you for acknowledging my work, I am happy to try and reach consensus on how best to represent the sources. I have been looking for an authoritative source that says specifically contraindicated and cannot find one. They seem to warn/caution of an increased risk of CNS adverse effects. I think that it is worth noting in the article as well that from the available evidence aspirin does not interact with quinolones. I would be ok with deleting the primary source which says contraindicated.

I did source the japanese source because I thought they were talking about various regulatory agencies world wide, as one would expect that if talking about just japan the guidance would be the same on all brands of oral/IV ciprofloxacin. I am happy to delete it though. If an clinical guidelines are found in different countries or other authoritative sources saying contraindicated then we can always discuss at a later date.

I disagree with your last point, they are talking about general CNS effects with quinolones. It is unclear because there are various neurotransmitter sites of action, possible DNA interactions, magnesium ion depletion, oxidative free radical toxicity etc. This is seperate, the NSAID interaction is not speculative, quinolones and NSAIDs are known to interact together at the GABAa receptor. I will read the source again just to be sure.--Literaturegeek | T@1k? 01:37, 13 December 2009 (UTC)

Ok, here are some quotes about from the review about the NSAID-quinolone interaction.

quinolone drug interactions are those with methylxanthine derivatives and certain NSAIDs, such as fenbufen or its metabolite 4-biphenylacetic acid (BPAA). These drug interactions are very important since they can result in considerable CNS toxicity.

As previously outlined, there is a good evidence that quinolones at high concentrations can inhibit GABA receptor binding, but when some quinolones are combined in vitro with certain NSAIDs or BPAA, their GABA receptor binding is dramatically potentiated

The review does say that it is unclear exactly what happens at the molecular level of the GABAa receptor to produce the significant synergistic antagonism of GABA binding but we are not discussing indepth technical specifics of the quinolone-nsaid GABA interaction in the interactions section.

The review also says that the interactions are important because of potentially considerable toxicity so I think that statement backs up that this is a potentially serious interaction.--Literaturegeek | T@1k? 01:53, 13 December 2009 (UTC)

I deleted the japanese primary source and the statement associated with it.--Literaturegeek | T@1k? 01:54, 13 December 2009 (UTC)

Fantastic - I concur. Now, I am tempted to rework the flow of the whole section but fear that would be misconstrued as an attempt to undo your work, so I'll just comment that reading from top to bottom of the 5 paragraphs:

1. NSAIDs and theophylline are mentioned, then caffeine and thyroxine in some detail. An overview of sorts might be better (CNS, renal, liver, and tendon issues could be highlighted)
2. NSAIDs in appropriate detail
3. cytochrome metabolism - BTW, this includes a list that oddly includes "theophylline" and "methylxanthines", the latter of which includes theophylline, doesn't it?
4. renal interactions smashed together with phenytoin, then back to probenecid (renal), then back to warfarin
5. achilles tendon rupture when combined with corticosteroids

IMHO this last one should be at the top of the section, and in fact this is the only subject of the FDA's black box warning. -- Scray (talk) 02:11, 13 December 2009 (UTC)

Great Scray. Much of the additions of text and sources was done by another editor DavidTfuller. My main work has been putting refs into inline citations, deleting unencyclopedic tone and undue weight. I have done some improved sourcing to certain parts of the article but more needs to be done. Much of the text was moved to more relevant articles such as antibiotic misuse to fix WP:UNDUE issues. I am happy if you did some editing to the section; I am a bit too tired at the moment. If there are disagreements we can always discuss on the talk page. It can be a bit difficult to find recent reviews which talk about ciprofloxacin specifically as there are certain interactions and adverse effects which are not quinolone drug class specific although most things can be sourced to secondary sources. Improved sourcing is one area that needs doing to this article.--Literaturegeek | T@1k? 02:54, 13 December 2009 (UTC)

Yes tendin toxicity should be at the top. Oh by the way, I said on your talk page that quinolones interaction with NSAIDs has UK CSM boxed warning, it is only for tendons and corticosteroids and elderly risk factors. There is a warning for NSAIDs but it is not in the CSM box. I don't like to misrepresent things, so I am correcting an error of fact I said. I noticed it after I typed it to you.

I shall comment tomorrow or day after about your other points. Too sleepy to think. :)--Literaturegeek | T@1k? 02:57, 13 December 2009 (UTC)

I've taken a stab at reworking the section in question. I've tried to keep references with relevant text, though some of them seem to be non-authoritative and will need to be replaced. Coordination with the rest of the article is also needed, but I too need some sleep. Nice work today! -- Scray (talk) 03:53, 13 December 2009 (UTC)

Looks like a good improvement to me. I merged social and economic impact into history. The section title is unusual for drug articles but content I thought was notable, so figured moving to history section was best to try and stay inline with WP:MEDMOS. What else needs improving in the interactions section do you feel Scray?--Literaturegeek | T@1k? 01:42, 14 December 2009 (UTC)

My primary concern about sourcing in the interactions is the multiple uses of what is currently ref #111, pointing to ciprofloxacin's entry in drugbank.ca. While that site seems respectable, it would be better to cite secondary sources that specifically support these interactions. I'm confident that they exist and they might be in the drugbank.ca entry, I just don't have time right now to find/add them. Otherwise, this is looking good! -- Scray (talk) 03:48, 14 December 2009 (UTC)

Okie dokie, no problems Scray. I have replaced the drugbank card with an FDA citation. So that is the interactions sections sorted out now? I think the ciprofloxacin article has improved even more this week. If you are ever game there are another 4 or 5 quinolone articles to work on. :)--Literaturegeek | T@1k? 18:06, 14 December 2009 (UTC)

Class: quinolones for fluoroquinolones?

The article seems to switch freely between these terms without rhyme or reason. Is one preferred? My sense is that "fluoroquinolones" is commonly used in many areas, but "quinolones" is considered the proper term for the class. -- Scray (talk) 03:35, 15 December 2009 (UTC)

The terms are used interchangably. I think it is accurate to say that the drug class is quinolone and fluoroquinolone is a drug class within a drug class. The only difference is the addition or lack of a fluorine ring to the molecule. Nalidixic acid one of the first quinolone which was (and still is occasionally) used for urinary tract infections is not a fluoroquinolone. Where nalidixic acid is mentioned in the article it would be inaccurate to refer to it as a fluoroquinolone. Then some or all of the contraindications for example would refer to the quinolone class regardless of the addition of a flourine atom. I have read over the article and when fluoroquinolone is used it seems to be the most accurate term to use and vice versa. So yes I think that there is rhyme and reason to it.--Literaturegeek | T@1k? 11:04, 15 December 2009 (UTC)

POV Bias?

Greetings,

I'm concerned that this article, as written, is too POV (negative) towards Cipro. The side effects may be strong, but that's because it is a strong drug and is, in some cases such as anthrax, the "last line of defense" against drug-resistant bacteria. Yes, it's been over-prescribed and that has changed its role somewhat. But this article should reflect mainstream, multiple outside sources in a manner that is objective and not biased in favor of exceptions to the rule.Ryoung122 02:33, 12 December 2011 (UTC)

miles company

The pharma provided notepad (back when they were allowed to) states a company "MILES". Not mentioned in article. — Preceding unsigned comment added by 208.54.32.138 (talk) 17:18, 24 April 2012 (UTC)

Removed Certain Misquotes and Controversial Statments that are Unsupported or Supported Only by Broken Links

Adjusted comment on IDSA recommendations for fluoroquinolones in CAP, in which the guidelines were misquoted. Clarified that the recommendations against the use of Cipro in CAP is due to its antibacterial spectrum, and not due to safety concerns as implied in the text. Removed statement that the FDA has limited use of cipro in pediatric population because of increased risk of death. No FDA document was provided to support this claim. Isolated reports of drug-associated deaths can be found for any drug as commonly used as this one, but such references do not support a claim that such events are the basis of an FDA decision in the absence of FDA documents stating that this is the case. Alfred Bertheim (talk) 13:58, 8 September 2012 (UTC)Alfred Bertheim

Repeated additions of text

A user is repeatedly adding text like this:

For the population less than 15 to 20 percent clarithromycin resistance,clarithromycin amoxicillin is treated as first choice of resistant is proved by some of the researchers.Varieties of therapies such as rescue theraphy was proposed with different combinations for the patients who are failed in a treatment.Many of the methods are done to prove the efficacy ciprofloxacin based regimen in the eradication of helicobacterpylori infection.according to the theory proposed in the first 14 patients amoxicillin and clarithromycin were failed to treat H.pylori infection.To know the presence of H.pylori in the body the biospsy specimens were taken one from the antrum and another one from the angulus and kept in 10 percent buffered formalin solution.After then the antrum biopsy is then transferred to portagem pylori follwed by steaking the antrum onto a columbus agar plates at a temperature of 37 degree celsius and incubated for 3 to 5 days by maintaining the 100% Humidity.By the researchers it was showed that the colony appearence.Further more Minimum inhibitory concentartion is proved by the intercept of the elliptical zone inhibition with the graded E-test strip.

To be included in this article, material needs to be more relevant, readable, and verifiable. -- Scray (talk) 15:15, 12 October 2012 (UTC)

Mechanism

I'm pretty sure the topoisomerases cipro acts on don't rewind DNA after replication, as declared in the intro. Gyrase and IV both unwind it before replication, and IV disentangles the newly-paired strands after replication. I'm not confident to make the edit because of how many people must've read this intro and been ok with it. Am I missing something?

173.25.54.191 (talk) 06:52, 10 April 2013 (UTC)

Adverse Events

I changed the intro sentence in the Adverse Events section which seemed slightly too rosy, as there does seem to be some disagreement in the literature around the relative safety of FQs vs other broad spectrum antibiotics, though any difference does not appear to me to be large. I also replaced the source cited in the opening sentence from an manufacturer-sponsored review to several that appeared to be indepdendent. I eliminated the sentence discussing the history of regulatory actions around the the black box warnings - this is already covered in a dedicated section just below and was redundant. Lastly I spelled out some of the rare, serious AEs seen in post-marketing surveillance. (Many of these are case reports summarized in secondary sources - How does MEDRS handle this?) My goal is eventually to pull the properly sourced AEs from the "Other Adverse Effects" section into this paragraph, and then eliminate the former.

I'm making a lot of changes here, but don't mean to be a cowboy. I'm certainly happy to discuss and work toward a consensus that properly reflects what is known from reliable sources. 98.155.21.76 (talk) 23:06, 29 December 2013 (UTC)

First line for UTIs

The article stated that ciprofloxacin is not recommended as a first-line antibiotic for urinary tract infections, giving this document as a source. The source actually says the opposite.

--Zwilson (talk) 15:53, 23 August 2012 (UTC)

Yes agree. Doc James (talk · contribs · email) (if I write on your page reply on mine) 01:50, 30 December 2013 (UTC)

Brand names

The article currently lists a large number of proprietary names supposedly used in the UK. Almost none are correct. When the drug was in patent the Bayer product was marketed as Ciproxin, but was mostly prescribed generically even then. Medical staff may use the term 'cipro' but this is an abbreviation of the generic name rather than a reference to the branded product sold in the US.

Generic drug naming is almost universal in Britain, where drug companies are not allowed to market prescription drugs directly to the general public. --Ef80 (talk) 13:32, 24 March 2014 (UTC)

Yes need refs so trimmed Doc James (talk · contribs · email) (if I write on your page reply on mine) 13:54, 24 March 2014 (UTC)

Litigation update August 2014

The previous text read:

===Litigation===

"A class action was filed against Bayer AG on behalf of employees of the Brentwood Post Office in Washington, D.C., and workers at the US Capitol, along with employees of American Media, Inc. in Florida and postal workers in general who alleged they suffered serious adverse effects from taking ciprofloxacin (Cipro) in the aftermath of the anthrax attacks in 2001. The action alleged Bayer failed to warn class members of the potential side effects of the drug, thereby violating the Pennsylvania Unfair Trade Practices and Consumer Protection Laws. According to the allegations within the complaint, exposed individuals were not informed of the true safety profile of ciprofloxacin, the high rate of adverse events associated with its use, or the availability of safer and equally effective alternative drugs. The class action was defeated and the litigation abandoned by the plaintiffs.

A similar action had been filed in New Jersey to cover New Jersey postal workers. Final disposition of that lawsuit is unknown. Following the addition of the black box warning in 2008, regarding tendon damage, product liability law firms began soliciting clients who have suffered a spontaneous tendon rupture following fluoroquinolone therapy."

References

Digging into this to get an update, I found the following:

• Bayer never recorded a reserve or even mentioned any of these lawsuits in its annual reports, as it would be required to do by SEC regulations if it considered them finanically material and likely to result in a judgment.
• The NJ suit involved only four plantiffs. I added this information, as the previous text seemed to imply a larger number of plantiffs. The fact that it was only four people likely explains the difficulty of findin updated info.
• I removed the statement about lawyers soliciting clients for tendonitis lawsuits

• Lawyers soliciting clients is, by itself, not notable
• On extensive searching I have not been able to find any reliable sources stating that a class action has been certified, or that any damages have been awarded, even though 6 years have passed since the black box warnings were placed on the label
• None of the cited sources for this statement were WP:RS, consisting of tort lawyer websites and a single informal newsite/blog that no longer hosted the story.
• As noted above, Bayer does not report setting aside any reserves, or even mention tendonitis lawsuits in its financial filings.

I recognize that deleting info about litigation is likely to be controversial, but would appreciate it if anyone objecting could address the points above. Formerly 98 (talk) 17:20, 16 August 2014 (UTC)

Also reduced the rather lengthy description of plantiff's allegations in defeated class action suit. Seems excessive detail given court ruled for defendent. Formerly 98 (talk) 01:34, 17 August 2014 (UTC)

broken references (page not found on external webpage)

link that says http://drugtopics.modernmedicine.com/drugtopics/data/articlestandard/drugtopics/252011/727243/article.pdf

should be corrected to be:

http://web.archive.org/web/20110626212051/http://drugtopics.modernmedicine.com/drugtopics/data/articlestandard/drugtopics/252011/727243/article.pdf — Preceding unsigned comment added by 134.228.22.122 (talk) 06:27, 22 January 2015 (UTC)

Used for and approved for

What the evidence supports is not necessarily the same as what a medication is approved for. FDA approval is more a legal / advertising issue and thus should be dealt with in a section on society and culture. We should use statements from medical bodies like the IDSA more for medical uses IMO. Doc James (talk · contribs · email) (if I write on your page reply on mine) 01:56, 30 December 2013 (UTC)

The article is unclear about whether cipro is useful against acute sinusitis: "Although [what does 'Although' mean here? Except?] for certain uses including acute sinusitis, lower respiratory tract infections and uncomplicated gonorrhea, ciprofloxacin is not considered a first-line agent." and "Similarly, ciprofloxacin is not recommended as a first-line treatment for acute sinusitis[28][29]" Carusus (talk) 19:30, 29 May 2015 (UTC)

Yes it works but there are other better treatments. Doc James (talk · contribs · email) 11:44, 30 May 2015 (UTC)

External links modified

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Anti-cancer properties of ciprofloxacin

Suppression of human prostate cancer cell growth by ciprofloxacin is associated with cell cycle arrest and apoptosis: http://www.ncbi.nlm.nih.gov/pubmed/12632069

Ciprofloxacin Mediated Cell Growth Inhibition, S/G2-M Cell Cycle Arrest, and Apoptosis in a Human Transitional Cell Carcinoma of the Bladder Cell Line http://clincancerres.aacrjournals.org/content/6/3/891.full

"Ciprofloxacin is a potential topoisomerase II inhibitor for the treatment of NSCLC" (Non-small-cell lung carcinoma (NSCLC)) http://www.spandidos-publications.com/ijo/41/6/1943

Ciprofloxacin can cause chemo-brain fog and memory problems (like anticancer chemotherapy) — Preceding unsigned comment added by 178.235.79.212 (talk) 22:40, 10 April 2016 (UTC)

CiproKills

User:CiproKills please discuss the changes you want to make, and their basis. Your edits are not coming from the sources cited, and that is an issue here. Thanks. Jytdog (talk) 05:40, 9 June 2016 (UTC)

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Could use an update

This article could use an update about uses. The reviews cited in medical use are all way old. Another thing for the to-do list. Jytdog (talk) 03:52, 10 January 2018 (UTC)

Side effects

The discussion of the permanence of side effects IMO best fits with the fact that most side effects are not permanent.

"In trials most of the adverse events were described as mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment.[25] Some side effects may be be permanent.[41]"

Others thoughts? Doc James (talk · contribs · email) 02:47, 10 January 2018 (UTC)

Do we need to state that more than one side effect can occur? IMO no as it is obvious. Doc James (talk · contribs · email) 02:51, 10 January 2018 (UTC)

The most recent information from the FDA safety announcement 2016 on Ciprofloxacin states that it is “associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.” This suggests that all these side effects can be disabling and potentially permanent. This is surely a public safety issue and needs to take a prominent place on this page. https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm --Wiki woms (talk) 03:03, 10 January 2018 (UTC)

It may seem obvious that more than one side effect can occur. But this warning is the first time that is has appeared in medical literature. I think that most people would be surprised to hear that an antibiotic could cause a multi symptom syndrome effecting your tendons, muscles, joints, nerves and central nervous system. Which may also be disabling and permanent.

I hope you can see my point of view and will agree this important safety information is needed on the page? Thanks Wiki woms (talk) 03:10, 10 January 2018 (UTC)

You are putting UNDUE weight on this. Per below we need to do a general update and see where the rest of the literature stands on this. The ref you keep posting everywhere is the first ref in the tendeonitis section already. Jytdog (talk) 03:54, 10 January 2018 (UTC)

Hi Jytdog, thanks for the reply. I can see your point that maybe it is obvious that multiple side effects can occur together. But I definitely think that disabling side effects needs to be added to the page.

The ref I keep posting is not the ref in the tendinitis section. I am referring to the 2016 FDA warning. Which has no mention on this page. It is the first warning that describes disabling multi system side effects, which may be permanent.

The ref in the tendinitis section is from the 2008 FDA black box warning. Which is just about tendinitis and tendon rupture. Here is a link about it https://www.webmd.com/osteoarthritis/news/20080708/fda-warning-cipro-may-rupture-tendons Wiki woms (talk) 04:13, 10 January 2018 (UTC)

Question

Do we need to say:

"These side effects can be disabling and may be permanent."

and than a couple of sentences latter again say

"Some side effects may be be permanent."? Doc James (talk · contribs · email) 15:07, 10 January 2018 (UTC)

You are correct. It does not need to be mentioned twice. But surely it would be better at the end of the first paragraph. As this describes the exact side effects the FDA state may be permanent. Rather than just saying some side effects may be permanent. Which is quite vague.

Also the page does not mention that side effects can be disabling. But this was the reason for the FDA 2016 warning.

The page makes reference to the FDA warnings from 2008 and 2013. But there is no ref to the most recent FDA warning from 2016. Surely this needs to be added to the page? Thoughts? Wiki woms (talk) 15:40, 10 January 2018 (UTC)

Hi Jytdog and Doc James, could you please explain why you do not want the words “disabling side effects” on this page. When this is precisely what the recent FDA warning from 2016 is about. In fact the title of the warning is “FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects” Wiki woms (talk) 18:09, 10 January 2018 (UTC)

This is a comment as an uninvolved observer who was wondering why mentions of this page kept flashing up on my watchlist, not as someone with any particular interest in the topic; Wiki woms, I think you may be reading way too much significance into an FDA advisory. The FDA operates (correctly) on the precautionary principle, and will document any and all potential side-effects or adverse interactions. Without knowing both the prevalence of side-effects (something that causes serious side-effects in one user in a billion isn't noteworthy; something that causes serious side-effects in one user in a hundred certainly is) it's at the very least misleading and at most actively giving undue weight to draw attention to the potential side effects. Likewise, it needs to be documented whether these side-effects occur at recommended dosage or only in overdoses or in people with compromised immune systems ("a multi symptom syndrome effecting your tendons, muscles, joints, nerves and central nervous system" could just as well describe extreme water toxicity, but we quite rightly don't scaremonger to our readers that drinking water is potentially poisonous), whether the warning is as the result of a single as-yet-unreplicated trial or whether the issues are confirmed, whether corresponding regulators in any other country have raised concerns (for cultural reasons based on the US's unusual healthcare funding model and the consequent prevalence of lawsuits, US authorities tend to be very knee-jerk), whether the warnings have led to a change in prescription patterns… Because Wikipedia's medical articles are often patients' first point of call when looking up "just what is this pill I've been prescribed?", we have a duty of care not only not to make any claim that isn't meticulously sourced and put in context, but not to make any claim that has the potential to mislead patients into not taking medication; consequently, this is a field in which we take WP:UNDUE very seriously. ‑ Iridescent 18:39, 10 January 2018 (UTC)

IMO the discuss of how common the permanent effects are belong in the paragraph on how common the permanent effects are. Rather than across two paragraphs. Doc James (talk · contribs · email) 18:45, 10 January 2018 (UTC)

Hi Iridescent, thank you for your message. You say I may be reading too much into the significance of the FDA 2016 warning. If you read through it, you will see the FDA are not only warning about disabling and permanent side effects. They also advise restricting fluoroquinolone antibiotic use for uncomplicated infections to patients who have no other treatment options.

To answer a couple more of your points. If you read further into the warning you will see that these adverse reactions occurred during the recommended dose and not overdose. They also occurred in previously healthy individuals.

Also if you doubt the significance of these FDA warnings. I would question why the page refers to the FDA warnings from 2008 and 2013. But no reference is made of the 2016 warning.

The 2 most common fluoroquinolones are Ciprofloxacin and Levofloxacin. If you look at the Wikipedia page for Levofloxacin, the FDA 2016 warning is referred to and is very prominent. I would ask why the Ciprofloxacin page does not refer to the same warning. The FDA 2016 warning applies to all fluoroquinolones.

Can you please respond with your thoughts? Doc James, could you also please respond? Thank you

Wiki woms (talk) 19:25, 10 January 2018 (UTC)

We reference the 2016 FDA a couple of time including to support that the side effects can be permanent. Doc James (talk · contribs · email) 21:01, 10 January 2018 (UTC)

Also just to add to my last comment. Regarding the question of whether these issues have just been raised in the US. The answer is they have been raised in other countries too.

In January 2017, Health Canada released a safety review on fluoroquinolones. It stated “Health Canada's review concluded that some of the known side effects (tendonitis/tendinopathy, peripheral neuropathy and central nervous system disorders) linked to the use of fluoroquinolones may be persistent and disabling”.

Also issues have been raised in Germany. Which has prompted the EMA to review fluoroquinoline safety. Their review is currently ongoing. “The European Medicines Agency (EMA) is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects are of particular importance when the medicines are used for less severe infections.

The review is at the request of the German medicines authority (BfArM) following reports of long-lasting side effects in the national safety database“. Wiki woms (talk) 21:06, 10 January 2018 (UTC)

Doc James thanks for your last message. I appreciate that you have mentioned side effects can be permanent. Can you please answer the following questions:

1. Why you are reluctant to say that side effects may also be disabling? (As this is what the 2016 warning is also about)

2. Why can the page not be edited to be the same as the Levofloxacin page, regarding the 2016 FDA warning?

The Levofloxacin page goes into far more detail about the 2016 FDA warnings and is far more prominent. I have noticed you are heavily involved in the editing of the Levofloxacin page. So I am confused as to why you think this information is necessary on the Levofloxacin page but not the Ciprofloxacin?

Wiki woms (talk) 21:20, 10 January 2018 (UTC)

Some thoughts: The FDA reference also restricts, or recommends restricting fluoroquinolones, to certain indications because of the risk of serious and sometimes persistent adverse effects. This information should be included in the medical uses section (perhaps also in the lead section) for all of the quinolones as the FDA is a high quality source.--Literaturegeek | T@1k? 21:47, 10 January 2018 (UTC)

Agreed literaturegeek Wiki woms (talk) 21:52, 10 January 2018 (UTC)

And old outdated sources (older than 5 years) that contradict the FDA should probably also be deleted, per WP:MEDRS.--Literaturegeek | T@1k? 22:04, 10 January 2018 (UTC)

Agreed literature geek. I have tried editing the page and provided the FDA 2016 warnings as reference. But Doc James just then deletes them, without good reason IMO.

Any suggestions how things could be changed? I think the Ciprofloxacin page should read similar to the Levofloxacin page regarding 2016 FDA warning. Doc James is also a regular editor of the Levofloxacin page. So I am confused as to why he thinks the information is necessary on the Levofloxacin page but not on the Ciprofloxacin page. In fact a lot of information on Ciprofloxacin page is well outdated.

As you can see from above. He’s seems unable to answer direct questions I’ve put to him. Confusing!! Wiki woms (talk) 22:27, 10 January 2018 (UTC)

Currently living with side effects of this medication not for the first time but this time in an enhanced manner...having been through cancer and multipule back surgery's..I can testify wholeheartedly that living with the side effects of the damage of this drug is life changing and full admission and awareness of the damage that can be caused needs to be known. Sunlovingdog (talk) 05:13, 13 January 2018 (UTC)

Proposal for Information to add to the article / Side Effects

Some side effects may be permanent and may worsen after discontinuing Ciprofloxacin. The constellation of multiple permanent disabling side effects, known as Fluoroquinolone-Associated Disability (FQAD), may occur. In comparison to other common antibiotics, Ciprofloxacin, Levofloxacin and Ofloxacin share the highest percentage of disability reports. Unbekannterweise (talk) 19:45, 14 October 2018 (UTC)

The page needs an update on side effects to reflect up to date information from the FDA, Health Canada and the European Medicines Agency (EMA).

All 3 of these agencies state that side effects can be disabling, but this is not mentioned at all on the page. It is also stated that these side effects are potentially permanent. This should all be in lead.

https://www.fda.gov/Drugs/DrugSafety/ucm511530.htm

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/61900a-eng.php

https://www.ema.europa.eu/en/news/fluoroquinolone-quinolone-antibiotics-prac-recommends-new-restrictions-use-following-review Wiki woms (talk) 20:31, 14 October 2018 (UTC)

Cartilage Damage Removed from Side-Effects with no reason by Boghog and Doc James

It is well known that Ciprofloxacin causes damage to cartilage as it has shown to be toxic to human chondrocytes. Even the paragraph was written neutral and was well cited with reliable sources it, the sources have first been degraded to "unreliable" by Boghog and finally the entire paragrpah has been removed by Doc James mentioning "trimmed primary sources". It is a shame that side effects that are even mentioned in the FDA approved package insert of Ciprofloxacin are removed. The Wiki aricle needs to reflect at least a summary of the package insert. — Preceding unsigned comment added by Unbekannterweise (talk • contribs) 12:28, 13 October 2018 (UTC)

Thanks for coming to talk. That was the correct thing to do. Yes, this and this were not good edits I left some notes at your talk page, at User talk:Unbekannterweise. Please read them and you will see part of what is wrong. Jytdog (talk) 17:02, 13 October 2018 (UTC)

Does it mean that making the previous edit according to the rules will have it kept in the article ? Just curious to know if the topic will be removed in general regardless citations/writing style. Unbekannterweise (talk) 20:16, 13 October 2018 (UTC)

Content in Wikipedia summarizes what reliable sources say. Different sources, different content. You seem to have overlooked the tendinitis section, which I believe deals with the adverse effects about which you are concerned. Jytdog (talk) 21:10, 13 October 2018 (UTC)

The tendinitis section only covers Tendinitis. Ciprofloxacin causes damage in adult human cartilage, which is important to mention as many patients affected from side-effects have developed Osteoarthritis due to that. I have reviewed the guidelines but could not identify why the sources I cited should be unreliable. Citing the guidelines: "PubMed is an excellent starting point for locating peer-reviewed medical literature reviews". The article further needs to cover mitochondiral damage, which is regarded as cause of most side effects. Nature published an article on that. It is one of the best journals in general: https://www.nature.com/articles/d41586-018-03267-5 . Other side effects typically assiciated with FQAD are missing as well - including the term FQAD in general. https://www.fda.gov/downloads/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/UCM550259.pdf This PDF of the FDA also compares common antibiotics, where FQs show to be responsible for the major share of disablities caused by antibiotics. Unbekannterweise (talk) 08:37, 14 October 2018 (UTC)

The FDA source is a good source because it complies with WP:MEDRS because it is a secondary source (it is a review of the evidence) and it is recent being written in 2017. Nature publishes both primary and secondary sources as well as occasionally opinion pieces - only the recent secondary sources are usually what we would use for medical content. We try to avoid adding primary sourced content, even if published by a reputable publisher or academic journal, again please refer to WP:MEDRS.--Literaturegeek | T@1k? 14:49, 14 October 2018 (UTC)

Why am I flagged to be engaged in an edit war after adding sources to FDA and Nature that were just mentioned to be a good sources. If it were an edit war I would try to add my previous paragraph again which I obviously didnt. If the references to nature and oxford journal are objected there is still no reason to remove my complete edit as most was referred to the FDA source. — Preceding unsigned comment added by Unbekannterweise (talk • contribs) 19:06, 14 October 2018 (UTC)

The nature article defines itself as a news piece which is usually not suitable for Wikipedia medical content. The paper about ciprofloxacin’s affect on topoisomerase is a single study (primary source) rather than a review of the subject matter, so is not a good source for this page. I do not know why the FDA source was reverted.--Literaturegeek | T@1k? 19:34, 14 October 2018 (UTC)

Thank you for the reply. Hopefully someone else will add the information related to the FDA link. I have added the summary here below. I will not do it as another revert for whatever reason will lock my account. Unbekannterweise (talk) 19:52, 14 October 2018 (UTC)

Doc James removed edits I made to this page back in January. The information I used was from the FDA and was cited. But this was still deleted. Doc James and Jytdog basically told me to stop making edits. They said they recognised the page was well overdue an update and they would edit it to reflect the new FDA information. But we are now 9 months later on and this hasn’t been done Wiki woms (talk) 19:27, 14 October 2018 (UTC)

Yes I keep getting distracted by other advocates on OTHER pages. There are too many people who show up to Wikipedia who do not give a flying fuck about what we do here, but demand that their badly sourced content get forced into Wikipedia RIGHT NOW. They refuse to stop and learn how to edit. Bloody fucking hell.

I do feel bad that I haven't got back to this but jesus fucking christ. it is not that hard to learn how to edit well. You just have stop and try to learn, and then go forward. There is no deadline here. This should get updated and should get updated right. I am very frustrated that neither of you will try to learn and that I have not gotten back to this. Jytdog (talk) 20:05, 14 October 2018 (UTC)

Just for reference: the current article contains many picked primary sources. Removing primary sources deliberately in a biased manner is not the way to achieve a neutral result of an article. Unbekannterweise (talk) 13:25, 15 October 2018 (UTC)

Jytdog, please calm down. I am more than happy to try and learn. But the problem is even when I edit text that is cited by a reliable source, you still delete it. Please see my edit you deleted on 10th January. I was simply adding that side effects can be disabling. The title of the source is “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects”. Can you please explain why you would delete that? The FDA, Health Canada and European Medicines Agency have all stated that Ciprofloxacin can have disabling side effects. It should be reflected on the page. Wiki woms (talk) 21:10, 14 October 2018 (UTC)

Moving forward: I suggest the FDA source be summarised carefully without going beyond what the source says.--Literaturegeek | T@1k? 17:53, 15 October 2018 (UTC)

To do this right we should gather up the relevant clinical guidelines and update Quinolone antibiotic and the same content should be put in the relevant specific drug articles. This is not about grabbing some source and slapping some crap into WP but doing the work to make high quality content. I will try to get to this, this week. But anybody can do this. Jytdog (talk) 18:22, 15 October 2018 (UTC)

Literaturegeek I completely agree. Thank you Jytdog, that would be great. Jytdog im happy to try and help with doing this if you would like me to? Wiki woms (talk) 01:25, 16 October 2018 (UTC)

If it is any help... the “adverse effects” section on the “Levofloxacin” page seems to better summarise the side effects of Quinolone antibiotics. Maybe this could be used as a starting point Wiki woms (talk) 01:37, 16 October 2018 (UTC)

Reminder - Someone should update the section. Unbekannterweise (talk) 20:59, 18 October 2018 (UTC)