Antibiotics Will Contain New Black Box Warning, FDA Says

WASHINGTON, D.C. - The FDA has ordered manufacturers of potent systemic a ntibiotic drugs to include a strict warning on their labels, alerting doctors and their patients of an increased risk of tendon rupture associated with the drugs.

The announcement comes several months after the consumer advocacy group, Public Citizen, petitioned the agency for the second time to include the black box warnings indicating a risk of tendon rupture on all fluoroquinolone antimicrobial drugs.

Public Citizen petitioned the FDA to include a black box warning on Levaquin in January. It was the second such petition filed by the group. …