FDA To Seek Black-Box Warning On Bayer's Cipro, Other Drugs

WASHINGTON -(Dow Jones)- 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 (JNJ) 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. Cipro and Levaquin belong to a class of antibiotics known as fluoroquinolones. The drugs are sold by several drug makers under various brand and generic names. The drug labels currently warn of the risk of tendon ruptures but don't include black-box warnings. A black-box warning is in bold type and is surrounded by a black box to make it stand out. It... [read full story]