Antibiotic Class Triggers Tendon Ruptures, Group Testifies
The U.S. Food and Drug Administration has ignored "long-standing evidence" that fluoroquinolone antibiotics can cause tendon ruptures, the consumer group Public Citizen testified Thursday in federal court.
In a statement, the group said it sued the FDA in the U.S. District Court for the District of Columbia. The group wants the agency to honor a petition filed 16 months ago asking the FDA to put a so-called "black box" warning on fluoroquinolone antibiotics, including Cipro and Levaquin. Such a warning, considered the agency's most serious labeling advisory, would alert doctors and patients of the risk of serious tendon injury, Public Citizen said.
From November 1997 through December 2005, the group said, the FDA 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.
"While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented," said Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group. "The current warning is buried in a long list of possible adverse reactions and is far too easy to miss," he added
http://www.drug-injury.com/druginjurycom/2006/08/antibiotics _ten.html
http://orthopedics.about.com/cs/ankleproblems/a/achilles_3.h tm
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