Charles Bennett MD PhD Chair of the Center for Economic Excellence in Medication Safety and Efficacy, University of South Carolina will be speaking at the PharmedOut’s 5th Annual Conference on June 11-12, 2015 at Georgetown University about Fluoroquinolones.
PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices. PharmedOut promotes evidence-based medicine by providing slideshows, videos, events, and links to pharma-free CME courses.
Should black box warnings for fluoroquinolones be revised: Is the bar set too high? Charles Bennett MD PhD, University of South Carolina The Food and Drug Administration (FDA) has received >150,000 reports of adverse events and 2,400 reports of deaths associated with the generically available levaquin and ciprofloxacin (two of the three FDA-approved fluoroquinolone antibiotics). Almost half of these reports are associated with psychiatric and neurologic toxicity. The current Black Box label warns of tendonitis, tendon rupture risks, and neurotoxicity occurring among persons with myasthenia gravis; Current product labels provide variable information on psychiatric toxicities.
The Southern Network on Adverse Reactions (SONAR) has been investigating these questions for four years, using a novel multi-pronged approach that includes animal studies and, in collaboration with persons who have self-reported quinolone toxicity, a review of FDA adverse event reports.
Is it time for a revision of the Black Box warnings?
Thank you Dr. Bennett for being a courageous champion in the fight to bring the truth about the Fluoroquinolone antibiotics to the world.