FDA petitioned for warnings on fluoroquinolones

The US Food and Drug Administration should strongly warn the public about the risk of tendon rupture associated with fluoroquinolone antibiotics, according to the consumer action group Public Citizen. The group issued a petition asking for a "black box" warning on the drugs' packaging .

Public Citizen joined with Illinois Attorney General Lisa Madigan's office, which also sent the agency an addendum to its earlier petition urging the agency to act on the group of drugs which includes Bayer's Cipro (ciprofloxacin), Bristol-Myers Squibbs' Tequin (gatifloxacin) and Ortho-McNeil's Levaquin (levofloxacin). Both Public Citizen's petition and the Illinois Attorney General's office letter to the FDA are available at www.worstpills.org.

"The numbers are startling. Tendon ruptures associated with these drugs continue to occur at a disturbing rate but could be prevented if doctors and patients were more aware of early warning signals, such as the onset of tendon pain, and switched to other antibiotics," said Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA must act and require black box warnings and patient information guides," he noted.