FDA News

FDA updates fluoroquinolone safety warnings

The FDA has approved changes to the labels of several fluoroquinolones warning of disabling and potentially permanent side effects when taken by mouth or injection, according to an announcement released today.

The update — which will apply to Avelox (moxifloxacin, Bayer HealthCare Pharmaceuticals), standard- and extended-release Cipro (ciprofloxacin, Bayer HealthCare Pharmaceuticals), Factive (gemifloxacin, LG Life Sciences), Levaquin (levofloxacin, Johnson & Johnson) and ofloxacin — was implemented due to associations with tendon, muscle, joint, nerve and central nervous system disabilities that could occur together in the same patient and be permanently debilitating, according to the release. The FDA will revise the boxed warning for these fluoroquinolones, as well as other parts of the drug label such as the “Warnings and Precautions” and “Medication Guide” sections.

Because of these risks and other cardiac, dermatologic and hypersensitivity reactions, the FDA recommends that fluoroquinolone use be reserved for patients with no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, or for serious infections where treatment benefits outweigh the risk for side effects.

According to the release, the FDA “is continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.”

The FDA has approved changes to the labels of several fluoroquinolones warning of disabling and potentially permanent side effects when taken by mouth or injection, according to an announcement released today.

The update — which will apply to Avelox (moxifloxacin, Bayer HealthCare Pharmaceuticals), standard- and extended-release Cipro (ciprofloxacin, Bayer HealthCare Pharmaceuticals), Factive (gemifloxacin, LG Life Sciences), Levaquin (levofloxacin, Johnson & Johnson) and ofloxacin — was implemented due to associations with tendon, muscle, joint, nerve and central nervous system disabilities that could occur together in the same patient and be permanently debilitating, according to the release. The FDA will revise the boxed warning for these fluoroquinolones, as well as other parts of the drug label such as the “Warnings and Precautions” and “Medication Guide” sections.

Because of these risks and other cardiac, dermatologic and hypersensitivity reactions, the FDA recommends that fluoroquinolone use be reserved for patients with no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, or for serious infections where treatment benefits outweigh the risk for side effects.

According to the release, the FDA “is continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.”