Fluoroquinolones Get New Safety Labeling, But Not A REMS

Risk of disabling, potentially permanent serious side effects that can occur together will be added to Cipro, Levaquin labels along with limitation against use for some self-limiting conditions unless there are no alternative treatments.

FDA's decision to order safety-related labeling changes for fluoroquinolones, including limitations on use in certain conditions, is in lock step with advisory committee recommendations, but stops short of some experts' call for a class-wide Risk Evaluation and Mitigation Strategy.

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