Identifying Genomic Risk Factors for Long-Term Disability Among Persons Who Receive One or Two Doses of Ciprofloxacin Save

Date Added
September 7th, 2016
PRO Number
Zaina Qureshi
Drug Studies, Genetics

The Southern Network on Adverse Reactions (SONAR) has just described a new adverse drug reaction termed fluoroquinolone (FQ)-associated disability (FQAD). The FQs ciprofloxacin, levofloxacin, and moxifloxacin are among the most commonly prescribed oral antibiotics administered to cancer patients and have Black Box warnings for tendinitis, tendon rupture, and neurotoxicity among myasthenia gravis patients. In 2014, SONAR filed a Citizen Petition with the Food and Drug Administration (FDA) requesting Black Box Warnings for severe FQ-associated psychiatric toxicity. Our case-definition included oral FQ use and: toxic psychoses, hallucinations, paranoia, suicidal thoughts or acts, altered mental status, depressed level of consciousness, amnesia, coma, memory impairment, and/or inability to work/perform daily activities for greater than one month. A November 2015 FDA Advisory Committee meeting reviewed risks and benefits of FQs. An FDA safety reviewer described FDA?s first reports of the same toxicity, termed FQAD, noting that these events were reported since 2010. It is imperative that if there is a genetic rationale for FQAD, it be identified. This study aims to find out association between fluoroquinolone exposure and genomic risk factors which leads to long-term disability.

Recruitment Contact
Zaina Qureshi


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