FDA Urges Warning For Cipro, Other Antimicrobials

Law360 (July 8, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has called for a boxed warning on Bayer's blockbuster Cipro, Johnson & Johnson's Levaquin and other antimicrobial drugs, citing tendon-related adverse events.

Fluoroquinolone antimicrobial drugs have been associated with pain, swelling, inflammation and even ruptured tendons, the FDA said Tuesday.

The FDA informed manufacturers that they must complete a risk evaluation and mitigation strategy to evaluate the drugs' costs and benefits. As part of its new authority under the Food and Drug Administration Amendments Act of 2007, the agency is...
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