The consumer group went to federal court today to force the agency to act on a petition filed last summer seeking stronger warnings about the risks of tendon rupture associated with fluroquinolones, a class of antibiotics used to treat bacterial infections. These includes Levaquin, a Johnson & Johnson med, and Bayer’s Cipro, along with other brand name versions and various generics. (lawsuit).
Although the labels warn of tendon ruptures, Public Citizen wants the FDA to place Black Box warnings on the drugs. J&J has said it believes the current tendon warning is adequate while Schering-Plough, which markets Cipro in the US as part of an agreement with Bayer, has said it won’t comment on Public Citizen’s petition.
The consumer group complains that the warning is buried a list of possible adverse reactions to the drugs and, therefore, is inadequate. Meanwhile, tendon injuries related to the drugs continue at an “alarming rate,” Public Citizen charges.
In a review of the FDA’s adverse event database, Public Citizen found 262 cases of tendon ruptures, 258 cases of tendonitis and 274 cases of other tendon disorders reported between November 1997 and December 2005 associated with the drugs, according to the lawsuit. Of those, 175 occurred since 2003. About 61 percent of the reported tendon problems were associated with Levaquin and 23 percent were associated with Cipro, Dow Jones writes. Since 2005, Public Citizen says an additional 74 tendon ruptures have been reported to the FDA.
“While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” says Sid Wolfe of Public Citizen. “The current warning is buried in a long list of possible adverse reactions and is far too easy to miss.”
Although the labels warn of tendon ruptures, Public Citizen wants the FDA to place Black Box warnings on the drugs. J&J has said it believes the current tendon warning is adequate while Schering-Plough, which markets Cipro in the US as part of an agreement with Bayer, has said it won’t comment on Public Citizen’s petition.
The consumer group complains that the warning is buried a list of possible adverse reactions to the drugs and, therefore, is inadequate. Meanwhile, tendon injuries related to the drugs continue at an “alarming rate,” Public Citizen charges.
In a review of the FDA’s adverse event database, Public Citizen found 262 cases of tendon ruptures, 258 cases of tendonitis and 274 cases of other tendon disorders reported between November 1997 and December 2005 associated with the drugs, according to the lawsuit. Of those, 175 occurred since 2003. About 61 percent of the reported tendon problems were associated with Levaquin and 23 percent were associated with Cipro, Dow Jones writes. Since 2005, Public Citizen says an additional 74 tendon ruptures have been reported to the FDA.
“While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” says Sid Wolfe of Public Citizen. “The current warning is buried in a long list of possible adverse reactions and is far too easy to miss.”
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