FDA SHOULD STOP IGNORING RISK OF TENDON RUPTURE FROM ANTIBIOTIC

January 4, 2008

Public Citizen Sues FDA to Force Agency to Act on Petition Seeking Stricter Antibiotic Warnings

Despite long-standing evidence that fluoroquinolone antibiotics such as CIPRO and LEVAQUIN can cause tendon ruptures, the Food and Drug Administration (FDA) has failed to increase its warnings to patients and physicians about the dangers of the medicines, Public Citizen told a federal court Thursday.

Public Citizen, the authors of WorstPills.org, sued in the U.S. District Court for the District of Columbia, asking the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. The FDA has failed to respond to the petition, which Public Citizen contends is a violation of the Administrative Procedure Act.

The petition. asked the agency to put a “black box” warning on fluoroquinolone antibiotics to make doctors and patients more aware of the risk of serious tendon injury before tendons actually rupture. A “black box” is the strongest type of warning the FDA can request.

The petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled.

Stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics, according to Dr. Sidney Wolfe, editor of WorstPills.org.

“While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” Wolfe said. “The current warning is buried in a long list of possible side effects and is far too easy to miss.”

From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. Because only a small fraction of cases are typically reported to the FDA, the actual number of ruptures and other tendon injuries attributable to the antibiotic is much higher.

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