2nd UPDATE FDA To Seek Strong Warning On J&J, Bayer Drugs (DJ)

By Jared A. Favole Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Tuesday requested that a class of antibiotic drugs used to treat bacterial infections include strong warnings about the risks of tendon rupture. The FDA wants to add black-box warnings, the strongest warning the agency issues, to a handful of drugs including Bayer AG's (BAYRY) Cipro and Johnson & Johnson's (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. The FDA said it will also ask the companies to create a medication guide - which will be given to patients - to alert them about possible side effects. The agency stopped short of saying letters should be sent to doctors notifying them of the labeling changes, a... [read full story]