FDA to Add Warning to Antibiotics – WSJ.com
By JARED A. FAVOLE
July 9, 2008; Page B7
WASHINGTON — The U.S. Food and Drug Administration will seek to add strong warnings about the risks of tendon rupture associated with a class of antibiotics used to treat bacterial infections.
The FDA wants to add black-box warnings, the strongest warning the agency issues, to a handful of drugs, including Bayer AG’s Cipro and Johnson & Johnson’s Levaquin. The move comes six months after the consumer group Public Citizen sued the FDA to require the agency to add black-box warnings to the drugs.
Serious reports of tendonitis and tendon rupture continue to increase with use of the drugs, prompting the FDA to ask companies to add the stronger warnings, the FDA said in a posting on its Web site Tuesday. Such ruptures most frequently involves the Achilles tendon, but also include ruptures of the shoulder, hand, biceps, and thumbs.
Black box warnings used to be for very serious, life-threatening problems in drugs. Now tendonitis and tendon rupture are life threats, or are so serious they warrant a Black Box? The elevation of known, well-documented drug side effects to Black Box status dilutes its meaning, and will ultimately require the formation of a new class of warnings.
Tendon ruptures aren’t benign. Neither are infections. Name me an antibiotic that wouldn’t rate a black box under the criteria used on the flouroquinolones, then wonder at what’s happened to the FDA.