Cipro Lawsuit Asked for Tough Warning on Tendon Damage
In January, the group Public Citizen sued the Food & Drug Administration (FDA) in an attempt to force the agency to require tougher warnings on Cipro and similar antibiotics regarding their association with tendon ruptures. Sixteen months prior, the group had petitioned the agency to include a black box warning on the drugs, but the FDA never responded.
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 had 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.
“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 said at the time. “The current warning is buried in a long list of possible adverse reactions and is far too easy to miss.
The lawsuit was filed in the U.S. District Court for the District of Columbia. Public Citizen said in its complaint that by failing to act upon petition, the FDA was violating the Administrative Procedure Act.
