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Fluoroquinolone-associated disability

Fluoroquinolone-Associated Disability ("FQAD") is an FDA formal review identification for a constellation of symptoms that have been identified in the FDA's Adverse Event Reporting System (FAERS) in review of data in the fluoroquinolone safety reports. This identification was formally published as a Briefing document for a joint meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.[1] These Adverse Reactions have been identified as leading to disability.[2] Individuals with FQAD are defined as "U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI)."[2]

Fluoroquinolone-Associated Disability is identified with the following Quinolone drugs: Avelox (Moxifloxacin) Cipro, Cipro XR, Proquin XR (Ciprofloxacin), Factive (gemifloxacin), Levaquin (Levofloxacin), Floxin (ofloxacin)

Criteria that the FDA is using for this class of adverse events are:

  • US Cases
  • Outcome: Disability only
  • Oral dosage forms

In the report on FQAD, the FDA has used the regulatory definition of disability as "a substantial disruption of a person's ability to conduct normal life functions" (21 CFR 314.80).[2] However this judgment review is not meant to represent a legal definition of this disruption. The FDA identifies a "healthy patient" as a person "able to perform all of the usual activities of daily living without significant restrictions prior to taking the fluoroquinolone."[2]

Adverse Reactions and events associated with FQAD that have been reported and documented are: Tendonitis and tendon rupture, Central Nervous System effects, Peripheral Neuropathy, Myasthenia Gravis Exacerbation, QT Prolongation Torsades de Pointes (TdP), Phototoxicity, Hypersensitivity, Arthritis, Brain Fog and Anxiety.

November 5, 2015 : A meeting was conducted by FDA regarding the risk - benefits while the affected speakers presented their cases.

Note: FQAD is not a diagnosis but a cluster of symptoms post dosage of quinolones. [3]

The U.S. FDA added a black box warning for fluoroquinolone antibiotics pertaining to peripheral nerve damage. In a communication dated 15 August 2013, the following warning was posted on the FDA website: "FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection." [4]

FDA Discussion on FQAD:

On Thursday, November 5, 2015, there was a meeting convened by the FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH. JOINT MEETING OF THE ANTIMICROBIAL DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE. Meeting was held on Thursday, November 5, 2015 8:01 a.m. to 6:05 p.m. FDA White Oak Campus Building 31, The Great Room, White Oak Conference Center, in Silver Spring, Maryland. Present were representatives from the FDA, The Pharmaceutical industry, and members of the general public, offering testimony regarding the use of fluoroquinolone antibiotics along with the subsequent risks and benefits of the "systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions." Presiding was Captain Monica Parise, the chairperson for the Antimicrobial Drugs Advisory Committee. This was a joint meeting of the Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA. After lengthy testimony and discussion, the committees decided that the current labeling for these drugs was unacceptable, recommending additional study, discussion and action to make both patient and practitioners aware of the potential for both temporary and permanent adverse reactions to the drugs, particularly requiring physicians to be more completely informed that fluoroquinolones are not to be used as a first line of defense against the three maladies discussed. The additional use of "REMS" (Risk Evaluation and Mitigation Strategy) to require practitioners to review the potential consequences of using these medicines with their patients was recommended as well. There are 476 pages of testimony and discussion in the record. (see reference for complete transcript)[5]