FDA News Release: FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs

Released : Tuesday, July 08, 2008 6:22 PM FDA NEWS RELEASE FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs Seeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupture The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects. The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the... [read full story]