FDA orders warning on some antibiotics

July 9, 2008

WASHINGTON Drug safety officials imposed yesterday the government's most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery. The Food and Drug Administration ordered makers of fluoroquinolone drugs - a potent class of antibacterials - to add a prominent "black box" warning to their products and develop new literature for patients emphasizing the risks. The two leading drugs covered by the warning are Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil.