Consumer group sues FDA for stronger antibiotics warning

WASHINGTON Public Citizen, a consumer group, is suing the Food and Drug Administration in an effort to force the agency to act on a petition seeking stronger warnings about the risk of tendon rupture associated with a class of antibiotics called fluoroquinolones according to the Associated Press. Cipro and Levaquin are types of fluoroquinolones.

In August 2006, Public Citizen filed a petition with the agency stating that the drugs should carry a “black-box” warning, as should medication guides often given to consumers with their prescriptions. 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.

In the petition, Public Citizen said, according to its review of the 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.

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.