FDA mandates black box warnings for certain antibiotics

NEW YORK Antibiotic drugs from Bayer, Johnson & Johnson and other companies will get black-box warnings from the Food and Drug Administration following reports of tendonitis and tendon rupture, the FDA announced Tuesday.

Fluoroquinolones, which include Bayer’s Cipro and J&J’s Levaquin, have been linked to increased risk of tendon ruptures in the Achilles tendon, shoulders, hands and biceps, particularly among patients older than 60.

The consumer advocacy group Public Citizen sued the FDA in January in the U.S. District Court for the District of Columbia to require it to add the warnings, considered the FDA’s strongest. Public Citizen had found almost 800 reports of tendon ruptures, tendonitis and other tendon disorders between 1997 and 2005 in the agency’s adverse event database. The drugs already include warnings about the risk of tendon ruptures, but not black-box warnings.

Cipro, known generically as ciprofloxacin, had sales of about $600 million in 2007, according to Bayer financial data. J&J reported that Levaquin, known generically as levofloxacin, had sales of $1.6 billion during the same period.