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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. These Adverse Reactions have been identified as leading to disability.〔 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)."〔(【引用サイトリンク】url=http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM467383.pdf )〕 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).〔 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."〔 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. 〔(【引用サイトリンク】url=http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM467383.pdf )〕 ==References== 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Fluoroquinolone-associated disability」の詳細全文を読む スポンサード リンク
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