The agency decided earlier this year to have its advisory committee examine the class of antibiotics because of mounting evidence of previously unknown, and sometimes permanent, side effects.
Fluoroquinolone labels need much stronger warnings about the risks for serious adverse events, including tendinitis and tendon rupture, and peripheral neuropathy, the panel said. Fluoroquinolones currently approved for one or more of these illnesses are ciprofloxacin, levofloxacin, ofloxacin, and gemifloxacin. In India, popular brands of fluoroquinolones include Ciplox, Ciprobid, Levoflox and Oflox.
The panel examined drugs for their safety when used to treat sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary disease.
The FDA’s Antimicrobial Drugs Advisory Committee (ADMAC) and Drug Safety and Risk Management Advisory Committee met jointly to discuss the use of fluoroquinolone antibacterial drugs for their safety when used to treat sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary disease.
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. Over 30 individuals spoke at an open public hearing about their own experiences with these effects, many saying they had lost years of their lives.
“Very rare side effects will be magnified when we abuse an antibiotic millions of times,” voting ADMAC member Antonio Carlos Arrieta, MD, division chief division of infectious diseases, Children’s Hospital of Orange County, California, said.