FDA first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture. In February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning. In August 2013, the agency required updates to the labels to describe the potential for irreversible peripheral neuropathy (serious nerve damage).

FDA Updates Safety Label Warnings for Fluoroquinolones Again

The agency has enhanced the warnings about these antibiotics’ association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. FDA says fluoroquinolones should be used for some conditions only when there are no other options available.

The U.S. Food and Drug Administration on July 26 approved stepped-up safety labeling changes for a class of antibiotics called fluoroquinolones, both to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. "Fluoroquinolones have risks and benefits that should be considered very carefully," said Dr. Edward Cox, M.D., director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "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."

Fluoroquinolones are antibiotics that kill or stop the growth of bacteria. They are effective in treating serious bacterial infections, but an FDA safety review found both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves, and the central nervous system. The side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent, according to the agency, which first added a Boxed Warning to fluoroquinolones in July 2008 for the increased risk of tendinitis and tendon rupture; in February 2011, the risk of worsening symptoms for those with myasthenia gravis was added to the Boxed Warning, and in August 2013 the agency required updates to the labels to describe the potential for irreversible peripheral neuropathy (serious nerve damage).

The latest enhanced warnings follow a May 12, 2016, drug safety communication advising that fluoroquinolones should be reserved for these conditions only when there are no other options available due to potentially permanent, disabling side effects occurring together. The drug safety communication also announced the required labeling updates to reflect this new safety information.

"Because the risk of these serious side effects generally outweighs 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. 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," FDA stated.

FDA-approved fluoroquinolones include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin and gemifloxacin (Factive).

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