FDA: Stronger Fluoroquinolone Warnings for Mental Health, Hypoglycemia

Marcia Frellick

July 10, 2018

The US Food and Drug Administration (FDA) today ordered label changes for fluoroquinolones to strengthen warnings about the antibiotics' risks for mental health side effects and serious blood sugar disturbances, according to a press release.

The label changes, which follow a series of warning additions over 10 years for the antibiotics, are also meant to make the warnings consistent whether the drugs are taken by mouth or injected.

"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," Edward Cox, MD, director of the FDA's Office of Antimicrobial Products, said in the release.

Updating the labels, which was prompted by a comprehensive review of the literature and adverse event reports, will help providers and patients weigh the risks and benefits, Cox added.

Fluoroquinolones approved by the FDA include levofloxacin (Levaquin), ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, moxifloxacin (Avelox), ofloxacin, gemifloxacin (Factive), and delafloxacin (Baxdela). There are more than 60 generic versions.

A range of mental health side effects are already described in the warnings and precautions section of the fluoroquinolone drug labeling, but they differ by drug.

On the new labels, mental health side effects must be listed separately from other central nervous system side effects and be consistent across all fluoroquinolones. The mental health side effects are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium, according to the FDA.

Additionally, the blood glucose disturbances section of the label for all systemic fluoroquinolones now must explicitly reflect the potential risk for coma with hypoglycemia.

The label changes follow several previous updates to risks linked with fluoroquinolones. Among them:

  • In 2008, the FDA added a boxed warning to fluoroquinolones for the increased risk for tendinitis and tendon rupture

  • In 2011, the FDA added to the boxed warning the risk for worsening symptoms in those with myasthenia gravis

  • In 2013, the agency required updated labels to reflect the potential for irreversible peripheral neuropathy

  • In 2016, the FDA enhanced warnings about the link between fluoroquinolones and disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system

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

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