The US Food and Drug Administration (FDA) approved updated labeling for
fluoroquinolone antibiotics today to warn against their use in patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections, unless those patients have no other treatment options.
The new labeling strengthens warnings about the risks for disabling and potentially permanent adverse effects including tendonitis and tendon rupture, central nervous system effects, myasthenia gravis exacerbation, peripheral neuropathy, prolongation of the QT interval, torsades de pointes, and phototoxicity. These effects can occur hours to weeks after exposure and can occur together.
"Fluoroquinolones have risks and benefits that should be considered very carefully," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "It's important that both health care providers and patients are aware of both the
risks and benefits
of fluoroquinolones and make an informed decision about their use."