FDA Updates Safety Warnings for Fluoroquinolones

July 17, 2018 04:18 pm News Staff

Following an extensive review of adverse event reports and case reports published in the medical literature, the FDA on July 10 announced changes(www.fda.gov) to the safety labeling of fluoroquinolones. The changes include strengthened warnings about the risks of mental health side effects and disturbances in blood sugar, and more consistent labeling for all fluoroquinolones administered orally or by injection.

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"The use of fluoroquinolones has a place in the treatment of serious bacterial infections -- such as certain types of bacterial pneumonia -- where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option," said Edward Cox, M.D., director of the FDA's Office of Antimicrobial Products, in a news release.(www.fda.gov) "The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use."

The labeling changes require that mental health side effects be listed separately from other central nervous system side effects, and that they be consistent across the labeling of all drugs in the class. Specific side effects to be included in the labeling are disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium.

In addition, the blood glucose disturbances subsection of the labeling for all systemic fluoroquinolones will be required to explicitly reflect the potential risk of hypoglycemic coma, particularly in older patients and in patients with diabetes who are taking other drugs to reduce blood glucose levels. Although hypoglycemia associated with fluoroquinolone is listed in the labels of five of the drugs, hypoglycemic coma currently is not.

The FDA first added a boxed warning to fluoroquinolones in July 2008(wayback.archive-it.org) for increased risk of tendonitis and tendon rupture. The agency published additional safety communications on fluoroquinolones in February 2011,(wayback.archive-it.org) August 2013,(wayback.archive-it.org) May 2016(www.fda.gov) and July 2016.(www.fda.gov)  

FDA-approved fluoroquinolones include levofloxacin, ciprofloxacin, moxifloxacin, ofloxacin, gemifloxacin and delafloxacin. Although delafloxacin was not included in the review, the FDA anticipates that the same adverse reactions are likely to occur with that drug; thus, the safety label changes will apply to all drugs in the class.

Related AAFP News Coverage
FDA Safety Alert

Use Fluoroquinolones Only as Drug of Last Resort for Some Infections

(7/27/2016)

Systemic Fluoroquinolones Pose Threat to Patients With Diabetes
Reports of Peripheral Neuropathy, Dysglycemia Suggest Caution When Prescribing

(8/27/2013)

Additional Resources
UpToDate: Fluoroquinolones(www.uptodate.com) (subscription required)