FDA: Antibiotics class must carry warning

FDA added new safety labeling changes for a class of antibiotics, fluoroquinolones (Levaquin, Cipro and other branded drugs), to enhance warnings about their association with disabling and potentially permanent side effects. Plus, the new labeling says that the drugs’ use should be limited in patients with less serious bacterial infections.

The safety labeling follows a May drug safety communication from FDA, advising that fluoroquinolones should be reserved for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections only when there are no other options available due to potentially permanent, disabling side effects occurring together.

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive). Generic forms of the drugs are also on the market.

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“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that both healthcare providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

While fluoroquinolones are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. “These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent,” the agency said.

Because the risk of these serious side effects generally outweigh the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA has determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options.

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For some serious bacterial infections, including anthrax, plague and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option.

The labeling changes include an updated Boxed Warning and revisions to the Warnings and Precautions section of the label about the risk of disabling and potentially irreversible adverse reactions that can occur together.

The label also contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and uncomplicated urinary tract infections. The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines.

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