Public Citizen seeks black-box on antibiotics

Although Cipro and Levaquin already contain warnings about possible tendon injuries on their labels, the consumer group Public Citizen asked the Food and Drug Administration to put the warnings in the black-box. The black-box is considered the FDA's toughest warning. The warning is in bold type and surrounded by a black box to make it more visible.

The reason the consumer group asked for the black-box is that they find that the warning is not adequate and that it is buried with the other adverse reactions especially because tendon ruptures associated with the drugs are occurring at a disturbing rate. The Public Citizen believes that the ruptures could be avoided and prevented if both doctors and consumers could recognize the early signs and could switch to another antibiotic.

Cipro and Levaquin belong to an antibiotics’ class called the fluoroquinolones. There are a few manufacturers of these drugs and a few brands. One of the companies that market the drugs feel that the labels adequately warn about the possible tendon risks while otyher companies did not comment.

FDA's adverse event database contains 262 reported cases of tendon ruptures, 258 cases of tendonitis and 274 cases of other tendon disorders between 1997 and 2005 associated with the use of fluoroquinolone antibiotics. The most frequent ruptures occur on the Achilles tendons, the rotator cuffs, the biceps, the hands and the thumbs. More adverse reactions occurred with Levaquin than Cipro but both drugs require more adequate warnings-the group reports.

They are waiting for the FDA to respond to their petition.