List of withdrawn drugs
Drugs or medicines may be withdrawn from commercial markets because of risks to patients, but also because of commercial reasons (e.g. lack of demand and relatively high production costs). Where risks or harms is the reason for withdrawal, this will usually have been prompted by unexpected adverse effects that were not detected during Phase III clinical trials, i.e. they were only made apparent from postmarketing surveillance data collected from the wider community over longer periods of time.
This list is not limited to drugs that were ever approved by the FDA. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market. Some drugs in this list (e.g. LSD) were never approved for marketing in the US or Europe.
|Adderall XR||2005||Canada||Risk of stroke The ban was later lifted because the death rate among those taking Adderall XR was determined to be no greater than those not taking Adderall.|
|Alatrofloxacin||2006||Worldwide||Liver toxicity; serious liver injury leading to liver transplant; death.|
|Alpidem (Ananxyl)||1995||Worldwide||Not approved in the US, withdrawn in France in 1994 and the rest of the market in 1995 because of rare but serious hepatotoxicity.|
|Alosetron (Lotronex)||2000||US||Serious gastrointestinal adverse events; ischemic colitis; severe constipation. Reintroduced 2002 on a restricted basis|
|Althesin (=Alphaxolone amineptine + Alphadolone)||1984||France, Germany, UK||Anaphylaxis.|
|Amineptine (Survector)||1999||France, US||Hepatotoxicity, dermatological side effects, and abuse potential. Reason:|
|Aminopyrine||1999||France, Thailand||risk of agranulocytosis; severe acne.|
|Amoproxan||1970||France||Dermatologic and ophthalmic toxicity.|
|Anagestone acetate||1969||Germany||Animal carcinogenicity.|
|Antrafenine||1984||France||Unspecific experimental toxicity.|
|Aprotinin (Trasylol)||2008||US||Increased risk of death.|
|Ardeparin (Normiflo)||2001||US||Not for reasons of safety or efficacy.|
|Astemizole (Hismanal)||1999||US, Malaysia, Multiple Nonspecified Markets||Fatal arrhythmia|
|Benoxaprofen||1982||Germany, Spain, UK, US||Liver and kidney failure; gastrointestinal bleeding; ulcers.|
|Beta-ethoxy-lacetanilanide||1986||Germany||Renal toxicity, animal carcinogenicity.|
|Bromfenac||1998||US||Severe hepatitis and liver failure (some requiring transplantation).|
|Bunamiodyl||1963||Canada, UK, US||Nephropathy.|
|Butamben (Efocaine)(Butoforme)||1964||US||Dermatologic toxicity; psychiatric Reactions.|
|Cerivastatin (Baycol, Lipobay)||2001||US||Risk of rhabdomyolysis|
|Chlormadinone (Chlormenadione)||1970||UK, US||Animal Carcinogenicity.|
|Chlormezanone (Trancopal)||1996||European Union, US, South Africa, Japan||Hepatotoxicity; Steven-Johnson Syndrome; Toxic Epidermal Necrolysis.|
|Cianidanol||1985||France, Germany, Spain, Sweden||Hemolytic Anemia.|
|Cisapride (Propulsid)||2000||US||Risk of fatal cardiac arrhythmias|
|Clioquinol||1973||France, Germany, UK, US||Neurotoxicity.|
|Clobutinol||2007||Germany||Ventricular arrhythmia, QT-prolongation.|
|Co-proxamol (Distalgesic)||2004||UK||Overdose dangers.|
|Dantron||1963||Canada, UK, US||Genotoxicity. withdrawn from general use in UK but permitted in terminal patients|
|Dexfenfluramine||1997||European Union, UK, US||Cardiac valvular disease.|
|Propoxyphene (Darvocet/Darvon)||2010||Worldwide||Increased risk of heart attacks and stroke.|
|Diethylstilbestrol||1970s||Risk of teratogenicity|
|Dimazole (Diamthazole)||1972||France, US||Neuropsychiatric reaction.|
|Dimethylamylamine (DMAA)||1983||US||Voluntarily withdrawn from market by Lily.:12 Reintroduced as a dietary supplement in 2006;:13 and in 2013 the FDA started work to ban it due to cardiovascular problems|
|Dinoprostone||1990||UK||Uterine hypotonus, fetal distress.|
|Dipyrone(Metamizole)||1975||UK, US, Others||Agranulocytosis, anaphylactic reactions.|
|Dithiazanine iodide||1964||France, US||Cardiovascular and metabolic reaction.|
|Dofetilide||2004||Germany||Drug interactions, prolonged QT.|
|Drotrecogin alfa (Xigris)||2011||Worldwide||Lack of efficacy as shown by PROWESS-SHOCK study|
|Efalizumab (Raptiva)||2009||Germany||Withdrawn because of increased risk of progressive multifocal leukoencephalopathy|
|Encainide||1991||UK, US||Ventricular arrhythmias.|
|Ethyl carbamate||1963||Canada, UK, US,||Carcinogenicity.|
|Etretinate||1989||France||Withdrawn US (1999). Risk for birth defects.|
|Fen-phen (popular combination of fenfluramine and phentermine)||1997||Cardiotoxicity|
|Fenclofenac||1984||UK||Cutaneous reactions; animal carcinogenicity.|
|Fenclozic acid||1970||UK, US||Jaundice, elevated hepatic enzymes.|
|Fenfluramine||1997||European Union, UK, US, India, South Africa, others||Cardiac valvular disease, pulmonary hypertension, cardiac fibrosis.|
|Fenoterol||1990||New Zealand||Asthma mortality.|
|Feprazone||1984||Germany, UK||Cutaneous reaction, multiorgan toxicity.|
|Flosequinan (Manoplax)||1993||UK, US||Increased mortality at higher doses; increased hospitalizations.|
|Gatifloxacin||2006||US||Increased risk of dysglycemia.|
|Gemtuzumab ozogamicin (Mylotarg)||2010||US||No improvement in clinical benefit; risk for death.|
|Grepafloxacin (Raxar)||1999||Withdrawn Germany, UK, US others||Cardiac repolarization; QT interval prolongation.|
|Hydromorphone (Palladone, extended release version)||2005||High risk of accidental overdose when extended release version (Palladone) administered with alcohol. Standard hydromorphone is sold in most of the world including the US|
|Indoprofen||1983||Germany, Spain, UK||Animal carcinogenicity, gastrointestinal toxicity.|
|Iodinated casein strophantin||1964||US||Metabolic reaction.|
|Iproniazid||1964||Canada||Interactions with food products containing tyrosine.|
|Isoxicam||1983||France, Germany, Spain, others||Stevens johnson syndrome.|
|Ketorolac||1993||France, Germany, others||Hemorrhage, renal Failure.|
|L-tryptophan||1989||Germany, UK||Eosinophilic myalgia syndrome. Still sold in the US|
|Levamisole (Ergamisol)||1999||US||Still used as veterinary drug and as a human antihelminthic in many markets; listed on the WHO List of Essential Medicines. In humans, it was used to treat melanoma before it was withdrawn for agranulocytosis.|
|Levomethadyl acetate||2003||US||Cardiac arrhythmias and cardiac arrest.|
|Lumiracoxib (Prexige)||2007–2008||Worldwide||Liver damage|
|Lysergic acid diethylamide (LSD)||1950s–1960s||Marketed as a psychiatric drug; withdrawn after it became widely used recreationally. Now illegal in most of the world.|
|Mebanazine||1975||UK||Hepatotoxicity, drug intereaction.|
|Methandrostenolone||1982||France, Germany, UK, US, others||Off-label abuse.|
|Methapyrilene||1979||Germany, UK, US||Animal carcinogenicity.|
|Methaqualone||1984||South Africa (1971), India (1984), United Nations (1971-1988)||Withdrawn because of risk of addiction and overdose|
|Metofoline||1965||US||Unspecific experimental toxicity.|
|Mibefradil||1998||European Union, Malaysia, US, others||Fatal arrhythmia, drug interactions.|
|Muzolimine||1987||France, Germany, European Union||Polyneuropathy.|
|Natalizumab (Tysabri)||2005–2006||US||Voluntarily withdrawn from US market because of risk of Progressive multifocal leukoencephalopathy (PML). Returned to market July, 2006.|
|Nefazodone||2007||US, Canada, others||Branded version withdrawn by originator in several countries in 2007 for hepatotoxicity. Generic versions available.|
|Nialamide||1974||UK, US||Hepatotoxicity, drug intereaction.|
|Nikethamide||1988||multiple markets||CNS Stimulation.|
|Nitrefazole||1984||Germany||Hepatic and hematologic toxicity.|
|Nomifensine||1981-1986||France, Germany, Spain, UK, US, others||Hemolytic Anemia, hepatotoxicity, serious hypersensitive reactions.|
|Oxeladin||1976||Canada, UK, US (1976)||Carcinogenicity.|
|Oxyphenbutazone||1984-1985||UK, US, Germany, France, Canada||Bone marrow suppression, Stevens–Johnson syndrome.|
|Oxyphenisatin (Phenisatin)||Australia, France, Germany, UK, US||Hepatotoxicity.|
|Ozogamicin||2010||US||No improvement in clinical benefit; risk for death; veno-occlusive disease.|
|Pemoline (Cylert)||1997||Canada, UK||Withdrawn from US in 2005. Hepatotoxicity Reason:hepatotoxicity.|
|Pentylenetetrazol||1982||Withdrawn for inability to produce effective convulsive therapy, and for causing seizures.|
|Pergolide (Permax)||2007||US||Risk for heart valve damage.|
|Perhexilene||1985||UK, Spain||Neurologic and hepatic toxicity.|
|Phenacetin||1975||Canada||An ingredient in "A.P.C." tablet; withdrawn because of risk of cancer and kidney disease Germany Denmark, UK, US, others Reason: nephropathy.|
|Phenformin and Buformin||1977||France, Germany US||Severe lactic acidosis|
|Phenoxypropazine||1966||UK||Hepatotoxicity, drug intereaction.|
|Phenylbutazone||1985||Germany||Off-label abuse, hematologic toxicity.|
|Phenylpropanolamine(Propagest, Dexatrim)||2000||Canada, US||Hemorrhagic stroke.|
|Pifoxime (=Pixifenide)||1976||France||Neuropsychiatric reaction.|
|Pirprofen||1990||France, Germany, Spain||Liver toxicity.:223|
|Prenylamine||1988||Canada, France, Germany, UK, US, others||Cardiac arrythmia and death.|
|Proxibarbal||1998||Spain, France, Italy, Portugal, Turkey||Immunoallergic, thrombocytopenia.|
|Rapacuronium (Raplon)||2001||US, multiple markets||Withdrawn in many countries because of risk of fatal bronchospasm|
|Remoxipride||1993||UK, others||Aplastic anemia.|
|Rimonabant (Acomplia)||2008||Worldwide||Risk of severe depression and suicide|
|Rofecoxib (Vioxx)||2004||Worldwide||Withdrawn by Merck & Co. Risk of myocardial infarction and stroke|
|Rosiglitazone (Avandia)||2010||Europe||Risk of heart attacks and death. This drug continues to be available in the US|
|Secobarbital||France, Norway, others.||Self poisoning.|
|Sertindole||1998||European Union||Arrhythmia and sudden cardiac death|
|Sibutramine (Reductil/Meridia)||2010||Australia, Canada, China, the European Union (EU), Hong Kong, India, Mexico, New Zealand, the Philippines, Thailand, the United Kingdom, and the United States||Increased risk of heart attack and stroke.|
|Sorivudine||1993||Japan||Drug interaction and deaths.|
|Sparfloxacin||2001||US||QT prolongation and phototoxicity.|
|Sulfacarbamide||1988||Germany||Dermatologic, hematologic and hepatic reactions.|
|Sulfamethoxypyridazine||1986||UK||Dermatologic and hematologic reactions.|
|Suloctidyl||1985||Germany, France, Spain||Hepatotoxicity.|
|Suprofen||1986-1987||UK, Spain, US||Flank pain, decreased kidney function.|
|Tegaserod (Zelnorm)||2007||US||Risk for heart attack, stroke, and unstable angina. Was available through a restricted access program until April 2008.|
|Temafloxacin||1992||Germany, UK, US, others||Low blood sugar; hemolytic anemia; kidney, liver dysfunction; allergic reactions|
|Temafloxacin||1992||US||Allergic reactions and cases of hemolytic anemia, leading to three patient deaths.|
|Temazepam (Restoril, Euhypnos, Normison, Remestan, Tenox, Norkotral)||1999||Sweden, Norway||Diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the US, but under strict controls.|
|Terfenadine (Seldane, Triludan)||1997-1998||France, South Africa, Oman, others, US||Prolonged QT interval; ventricular tachycardia|
|Terodiline (Micturin)||1991||Germany, UK, Spain, others||Prolonged QT interval, ventricular tachycardia and arrhythmia.|
|Tetrazepam||2013||European Union||Serious cutaneous reactions.|
|Thalidomide||1961||Germany||Withdrawn because of risk of teratogenicity; returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules|
|Thenalidine||1960||Canada, UK, US||Neutropenia|
|Thioridazine (Melleril)||2005||Germany, UK||Withdrawn worldwide due to severe cardiac arrhythmias|
|Ticrynafen(Tienilic acid)||1980||Germany, France, UK, US others||Liver toxicity and death.|
|Tolcapone (Tasmar)||1998||European Union, Canada, Australia||Hepatotoxicity|
|Tolrestat (Alredase)||1996||Argentina, Canada, Italy, others||Severe hepatotoxicity|
|Triazolam||1991||France, Netherlands, Finland, Argentina, UK others||Psychiatric adverse drug reactions, amnesia.|
|Triparanol||1962||France, US||Cataracts, alopecia, ichthyosis.|
|Troglitazone (Rezulin)||2000||US, Germany||Hepatotoxicity|
|Trovafloxacin (Trovan)||1999-2001||European Union, US||Withdrawn because of risk of liver failure|
|Valdecoxib (Bextra)||2004||US||Risk of heart attack and stroke.|
|Zimelidine||1983||Worldwide||Risk of Guillain–Barré syndrome, hypersensitivity reaction, hepatotoxicity banned worldwide.|
|Zomepirac||1983||UK, Germany, Spain, US||Anaphylactic reactions and non-fatal allergic reactions, renal failure|
- Branch, Government of Canada, Health Canada, Public Affairs, Consultation and Communications. "Health Canada - Home Page". Retrieved 28 November 2016.
- Qureshi, ZP; Seoane-Vazquez, E; Rodriguez-Monguio, R; Stevenson, KB; Szeinbach, SL (July 2011). "Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.". Pharmacoepidemiology and drug safety. 20 (7): 772–7. PMID 21574210. doi:10.1002/pds.2155.
- Fung, M.; Thornton, A.; Mybeck, K.; Wu, J. H.-h.; Hornbuckle, K.; Muniz, E. (1 January 2001). "Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999". Therapeutic Innovation & Regulatory Science. 35 (1): 293–317. doi:10.1177/009286150103500134.
- "WHO Drug Information Vol. 8, No. 2, 1994, page 64" (PDF). Retrieved 28 November 2016.
- Berson A, et al. (2001) Toxicity of alpidem, a peripheral benzodiazepine receptor ligand, but not zolpidem, in rat hepatocytes: role of mitochondrial permeability transition and metabolic activation. J Pharmacol Exp Ther. 299(2):793-800.
- DrugBank. "Amineptine". Retrieved 24 September 2013.
- FDA Response to Citizen Request re Ardeparin
- DrugBank. "Bezitramide". Retrieved 24 September 2013.
- DrugBank. "Bunamiodyl". Retrieved 24 September 2013.
- WHO. Consolidated List of Products - Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or Not Approved by Governments, Twelfth Issue - Pharmaceuticals. United Nations - New York, 2005
- Department of Economic and Social Affairs of the United Nations Secretariat Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments Twelfth Issue: Pharmaceuticals United Nations – New York, 2005
- Schubert-Zsilavecz, Manfred (2011). "Arzneimittelrücknahmen Rückrufe im Rückblick". Pharmazeutische Zeitung (German). Retrieved 25 September 2013.
- DrugBank. "Dantron". Retrieved 24 September 2013.
- "Press Announcements - Xanodyne agrees to withdraw propoxyphene from the U.S. market". Retrieved 28 November 2016.
- Col John Lammie et al. Report of the Department Of Defense: 1,3 Dimethylamylamine (Dmaa) Safety Review Panel June 3, 2013
- FDA. "Stimulant Potentially Dangerous to Health, FDA Warns". Retrieved 26 January 2014.
- Drotrecogin Alfa (Activated) in Adults with Septic Shock , N Engl J Med 2012; 366:2055-2064, May 31, 2012, doi:10.1056/NEJMoa1202290
- "Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy". Press release. London, UK: European Medicines Agency. 25 October 2011. Archived from the original on 26 October 2011. Retrieved 26 October 2011.
- DrugBank. "Ethyl carbamate". Retrieved 24 September 2013.
- DrugBank. "Fenfluramine". Retrieved 24 September 2013.
- DrugBank. "Iproniazid". Retrieved 24 September 2013.
- Centers for Disease Control and Prevention (CDC) (December 2009). "Agranulocytosis associated with cocaine use - four States, March 2008-November 2009". Morb. Mortal. Wkly. Rep. 58 (49): 1381–5. PMID 20019655.
- Nancy Y Zhu; Donald F. LeGatt; A Robert Turner (February 2009). "Agranulocytosis After Consumption of Cocaine Adulterated With Levamisole". Annals of Internal Medicine. 150 (4): 287–289. PMID 19153405. doi:10.7326/0003-4819-150-4-200902170-00102. Retrieved 2009-10-07.
- Kinzie, Erik (April 2009). "Levamisole Found in Patients Using Cocaine". Annals of Emergency Medicine. 53 (4): 546–7. PMID 19303517. doi:10.1016/j.annemergmed.2008.10.017. Retrieved 2009-08-18.
- Central Drugs Standard Control Organization. "Drugs Banned In India". Ministry of Health and Family Welfare, Government of India. Archived from the original on 21 February 2015. Retrieved 24 September 2013.
- "Drug Effects - Methaqualone". South African Police Service. Retrieved 24 September 2013.
- Cosgrove-Mather, Bootie (December 5, 2007). "Anti-Depressant Taken Off Market". CBS NEWS. Retrieved 29 September 2013.
- DrugBank. "Oxeladin". Retrieved 24 September 2013.
- DrugBank. "Oxyphenbutazone". Retrieved 24 September 2013.
- Biron, P (15 May 1986). "Withdrawal of oxyphenbutazone: what about phenylbutazone?". CMAJ : Canadian Medical Association Journal [Journal de l'Association medicale canadienne]. 134 (10): 1119–20. PMC . PMID 3697857.
- DrugBank. "Pemoline". Retrieved 24 September 2013.
- DrugBank. "Phenacetin". Retrieved 24 September 2013.
- Wysowski, Diane K. (2005). "Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002: The Importance of Reporting Suspected Reactions". Archives of Internal Medicine. 165 (12): 1363–9. PMID 15983284. doi:10.1001/archinte.165.12.1363.
|last2=in Authors list (help)
- Commissioner, Office of the. "Safety Alerts for Human Medical Products - Phenylpropanolamine hydrochloride (PPA)". Retrieved 28 November 2016.
- DrugBank. "Phenylpropanolamine". Retrieved 24 September 2013.
- DrugBank. "Prenylamine". Retrieved 24 September 2013.
- DrugBank. "Sertindole". Retrieved 24 September 2013.
- "Sibutramine (brand name Reductil) Information - Australia". Abbott Laboratories. 2010. Archived from the original on 2010-10-14. Retrieved 2010-10-08.
- Health Canada Endorsed Important Safety Information on MERIDIA (Sibutramine Hydrochloride Monohydrate): Subject: Voluntary withdrawal of Meridia (sibutramine) capsules from the Canadian market.
- "Notification of Termination of Production, Sale, and Usage of Sibutramine Preparations and Their Active Pharmaceutical Ingredient". sda.gov in People's Republic of China. October 30, 2010. Retrieved 2011-05-21.
- (in German) Sibutramin-Vertrieb in der Europäischen Union ausgesetzt . Abbott Laboratories in Germany. Press Release 2010-01-21. Retrieved 2010-01-27
- "De-registration of pharmaceutical products containing sibutramine" (Press release). info.gov in Hong Kong. November 2, 2010. Retrieved 2010-11-08.
- "Banned Medicines" (Press release). Ministry of Health and Family Welfare. February 10, 2011. Retrieved 2011-03-15.
- "Withdrawal of Sibutramine (Reductil) in New Zealand" (Press release). MedSafe in New Zealand. October 11, 2010. Archived from the original on October 14, 2012. Retrieved 2012-11-06.
- "FDA warns online sellers of banned slimming pills". January 12, 2014. Retrieved February 20, 2014.
- "Thai FDA reveals voluntary withdrawal of sibutramine from the Thai market" (PDF) (Press release). Food and Drug Administration of Thailand. October 20, 2010. Retrieved 2010-12-22.
- "Top obesity drug sibutramine being suspended". BBC News. 2010-01-22. Retrieved 2010-01-22.
- Rockoff, Jonathan D.; Dooren, Jennifer Corbett (October 8, 2010). "Abbott Pulls Diet Drug Meridia Off US Shelves". The Wall Street Journal. Retrieved 8 October 2010.
- H. Gurdon: Japan bans shingles drug after deaths BMJ 1994;309:627
- Paar, W.D; Müller-Jakic. "Ruhen der Zulassung Tetrazepam haltiger Arzneimittel in der EU (German)" (PDF). Sanofi-Aventis Deutschland GmbH. Retrieved 25 September 2013.
- Luippold, Gerd (2006). "Renaissance des Contergan-Wirkstoffs". Pharmazeutische Zeitung (German). Retrieved 25 September 2013.
- Drugbank. "Thenalidine". Retrieved 24 September 2013.
- Purhonen, M; Koponen, H; Tiihonen, J; Tanskanen, A (November 2012). "Outcome of patients after market withdrawal of thioridazine: A retrospective analysis in a nationwide cohort". Pharmacoepidemiology and Drug Safety. 21 (11): 1227–1231. PMID 22941581. doi:10.1002/pds.3346.
- "SHARED CARE PROTOCOL Thioridazine" (PDF). NHS Lothian Joint Formulary. March 2012.
- DrugBank. "Triazolam". Retrieved 24 September 2013.
- Fagius J, et al. Guillain–Barré syndrome following zimeldine treatment J Neurol Neurosurg Psychiatry. 1985 Jan;48(1):65-9.
- Pubchem record says "withdrawn in 1983"
- DrugBank. "Zimelidine". Retrieved 24 September 2013.
- CDER Report to the Nation: 2005 Has a list of US withdrawals through 2005.