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Antibiotic Lawsuit Seeks Stronger Warnings on Cipro, Levaquin and Others for Tendon Damage

Jan 4, 2008 | Parker Waichman Alonso LLP

Cipro, Levaquin and other antibiotics known as fluoroquinolones have long been known to cause serious side effect, including tendon damage.  Yet despite massive amounts of evidence, the Food & Drug Administration (FDA) has not required the makers of Cipro, Levaquin and other fluoroquinolone antibiotics to add warning labels about their links to ruptured tendons and other tendon problems.  Now, the consumer advocacy group Public Citizen is trying to force the FDA to act, and has taken it to court in attempt to compel the agency to add black box warnings about tendon problems to the labels of these antibiotics.

Fluoroquinolones are used to treat bacterial infections in many different parts of the body. They work by killing bacteria or preventing their growth.  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. But Public Citizen contends that only a small fraction of cases are typically reported to the FDA, so the actual number of ruptures and other tendon injuries attributable to the antibiotic is probably much higher.

Public Citizen announced yesterday that it had sued the FDA in the U.S. District Court for the District of Columbia over the issue of floroquinolone antibiotics and tendon damage.  Public Citizen wants the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. So far, the FDA has failed to respond to the petition, which asked the agency to put a “black box” warning on fluoroquinolone antibiotics to make doctors and patients are  more aware of the risk of serious tendon injury before tendons actually rupture.

The Public Citizen 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.  In a press release announcing the antibiotic lawsuit, Public Citizen asserted that stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics.  “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.”

Public Citizen said in its complaint that by failing to act upon its fluoroquinolone petition, the FDA is violating the Administrative Procedure Act.