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FDA Mandates Black Box Warning for Some Antibiotics
Date:7/8/2008

s. Tendons are the areas that connect muscles to joints.

Prior to requesting the black box warning, the FDA had been sued by the consumer group Public Citizen for ignoring "long-standing evidence" that fluoroquinolones can cause tendon ruptures. The consumer group had been calling upon the agency to add such a warning since 2006.

In January, Public Citizen said that from November 1997 through December 2005, the FDA had received 262 reports of tendon ruptures among fluoroquinolone users. Most involved ruptures of the Achilles' tendon. The group also cited hundreds of additional cases of tendonitis and other tendon disorders.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones don't treat viral infections such as colds or the flu.

More information

For more on antibiotics, visit the U.S. National Library of Medicine.



SOURCE: July 8, 2008, U.S. Food and Drug Administration


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