FDA Panel Says Fluoroquinolones Need Stronger Warnings

The FDA's Antimicrobial Drugs Advisory Committee (ADMAC) and the Drug Safety and Risk Management Advisory Committee met jointly to discuss the use of fluoroquinolone antibacterial drugs for treatment of acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis in those with chronic obstructive pulmonary disease (ABECB-COPD), and uncomplicated urinary tract infection.

Fluoroquinolone labeling currently has warnings about the risks for tendonitis, tendon rupture, central nervous system effects, peripheral neuropathy, myasthenia gravis exacerbation, QT prolongation and Torsades de Pointes, phototoxicity, and hypersensitivity. But panel members called for stronger wording, with some suggesting the risks be called out with a black box warning.

These adverse effects have been seen in larger numbers of patients since the FDA approved fluoroquinolone drugs, and many believe the FDA should update the labels accordingly. More than 30 individuals spoke at an open public hearing about their own experiences with these effects, many saying they had lost years of their lives.

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