Recent News, Recalls and Safety Alerts

FDA Warning: Cipro May Rupture Tendons
Agency Issues 'Black Box' Warning for Antibiotics Known as Fluroquinolones
(WebMD Health News, July 8, 2008)
Federal regulators are ordering new warnings on Cipro and similar antibiotics because of increased risk of tendinitis and tendon rupture. The new warnings apply to fluoroquinolones, a class of antibiotics that includes the popular drug Cipro. The FDA has told companies that the drugs must now carry "black box" warnings alerting doctors and patients that the drugs can increase risk of tendinitis and tendon rupture in some patients. Read the article.

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
Seeks to Strengthen Warnings Concerning Increased Risk of Tendinitis and Tendon Rupture
(FDA News, July 8, 2008)
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.. Read the FDA News Alert.