In May, the federal agency said fluoroquinolone antibiotics have “serious side effects” that “generally outweigh the benefits” for certain patients.
Now, the FDA has determined that fluoroquinolones should only be used in patients for which there is no other treatment option available, or when the benefits outweigh the risks, such as patients with serious bacterial infections like anthrax, plague or bacterial pneumonia.
The new labels for fluoroquinolones include an updated boxed warning and changes to the warnings and precautions section and new limitation-of-use statements.
“It is 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,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
The labeling changes affect FDA-approved fluoroquinolones, including levofloxacin, ciprofloxacin, ciprofloxacin extended-release tables, moxifloxacin, ofloxacin and gemifloxacin.
See the full announcement here.
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