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KEYCODE BAYER #337

January 03, 2008

FDA Sued Over Antibiotics Warnings

Consumer Group Sues Federal Drug Administration Over Cipro, Levaquin Warnings

The consumer group Public Citizen sued the U.S. Food and Drug Administration in federal court Thursday to force the agency to act on a petition seeking stronger warnings about the risks of tendon rupture associated with a class of antibiotics.
In August 2006, Public Citizen filed a petition with the agency stating that products like Bayer's Cipro and Johnson & Johnson's Levaquin should carry a "black-box" warning, as should medication guides often given to consumers with their prescriptions.
Cipro and Levaquin belong to a class of antibiotics known as fluoroquinolones. The drugs are sold by several drug makers under various brand and generic names.
The drug labels do warn of the risk of tendon ruptures but the warning is not contained in a black box, which is considered the FDA's toughest warning.
A black-box warning is in bold type and is surrounded by a black box to make it stand out. It typically appears at the top of drug labels, and any advertising of products that carry black boxes must also include warning information as part of the advertisement.
Johnson & Johnson has said it believes the current tendon warning is adequate, while Schering-Plough Corp., which markets Cipro in the U.S. as part of an agreement with Bayer, has said it won't comment on Public Citizen's petition.
Public Citizen said the tendon warning is buried in a list of possible adverse reactions to the drugs and does not adequately warn consumers and health-care providers of the risk. The current tendon warning was added after Public Citizen petitioned the agency in 1996.
"Stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics, said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
The lawsuit, filed Thursday in the U.S. District Court for the District of Columbia, says the agency is violating the Administrative Procedure Act by not acting upon the petition.
An FDA spokesman confirmed the agency received a copy of the lawsuit, but said the agency would not comment on it.
In the petition, Public Citizen said according to its review of FDA's adverse event database that 262 cases of tendon ruptures, 258 cases of tendinitis and 274 cases of other tendon disorders were reported between November 1997 and Dec. 31, 2005, associated with fluoroquinolone antibiotics. 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.
Since 2005, Public Citizen said an additional 74 tendon ruptures have been reported to the FDA. An adverse event report, however, doesn't necessarily mean a particular product has caused a problem and requires additional follow up. The FDA uses such reports to flag possible safety problems with drugs and medical devices.