Processing Magazine

FDA sued over antibiotics warnings

January 7, 2008
The consumer group Public Citizen sued the U.S. Food and Drug Administration in federal court recently to force the agency to act on a petition seeking stronger warnings about the risks of tendon rupture associated with a class of antibiotics, according to the Associated Press. 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. 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. The lawsuit, filed 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.