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FDA Panel Says Fluoroquinolones Need Stronger Warnings
November 6, 2015 -- Fluoroquinolone labels need much stronger warnings about the risks for serious adverse events, including tendinitis and tendon rupture, prolongation of the QT interval, and peripheral neuropathy, according to a joint panel of the US Food and Drug Administration (FDA).
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. The panel also voted overwhelmingly that the benefits and risks for the systemic fluoroquinolone antibacterial drugs do not support the current labeled indications for the treatment of ABS (unanimous), ABECB-COPD (2 yes, 18 no, 1 abstention), or uncomplicated urinary tract infection (1 yes, 20 no).
Fluoroquinolones currently approved for one or more of these illnesses are ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, and gemifloxacin.
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.
"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, Orange, California, said.
The Infectious Diseases Society of America recommends fluoroquinolones for second-line treatment of patients with allergies to other antibiotics, patients with treatment failure to primary antibiotics, and patients with pathogens that are resistant to first-line antibacterials.
The treatment benefits of antibacterial medications for ABS and mild ABECB-COPD are, at best, very moderate.
Acute Bacterial Sinusitis
It can often be difficult to differentiate patients with viral sinusitis from patients with bacterial sinusitis. Even in studies of patients more likely to have ABS, the treatment effect of the drug was often small, although a large proportion of patients treated with placebo had favorable clinical responses.
A meta-analysis of nine randomized trials among 2547 patients with ABS was unable to identify patients for whom antibacterial treatment would be beneficial, and found that antibacterial treatment might even be harmful.