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Public Citizen Urges Antibiotic Warnings

Posted on: Tuesday, 29 August 2006, 12:00 CDT

Public Citizen Tuesday urged U.S. Food and Drug Administration to place a black box warning of tendon rupture on fluoroquinolones.

The consumer advocacy group also urged the FDA in a petition to require pharmacists to issued patient medication guides that carry the warning.

Illinois Attorney General Lisa Madigan joined Public Citizen in calling for the black box warning.

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.

Fluoroquinolones include Bayer's Cipro, Aventis' Penetrex, Bristol-Myers Squibb's Tequin, Ortho-McNeil's Levaquin and Merck's Noroxin.

Public Citizen said its review of the FDA's adverse-event database showed 262 cases of tendon ruptures associated with fluoroquinolones from 1997 to 2005. Approximately 61 percent of the ruptures were associated with Levaquin, and 23 percent were associated with Cipro.

Source: United Press International

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