Public Citizen has filed a federal court suit asking thatthe FDA be forced to act on a petition the group says has been unanswered for16 months, seeking a black-box warning on fluoroquinolone antibiotics (e.g.,Cipro, Levaquin, and others) on the risk of serious tendon injury associatedwith the drug’s use.
Public Citizen says the FDA has failed to act on itspetition despite “long-standing evidence that fluoroquinolone antibiotics cancause tendon ruptures.”
It says a black-box warning would help make doctors andpatients more aware of the risk before tendons actually rupture. The petitionalso asked the FDA to send a warning letter to physicians and to require anFDA-approved medication guide to be dispensed with prescriptions.
“While FDA sits idly by and ignores the problem, more peoplewill suffer serious tendon ruptures that could have been prevented,” saysPublic Citizen Health Research Group director Sidney Wolfe. “The currentwarning is buried in a long list of possible adverse reactions and is far tooeasy to miss.”
Public Citizen reports that from November1997 to December 2005, the FDA received 262 reports of tendon ruptures, mainlyof the Achilles tendon; 258 cases of tendonitis; and 274 cases of other tendondisorders in patients using fluoroquinolone antibiotics. An additional 74tendon ruptures, it says, have subsequently been reported to the FDA, for atotal of 336.
From the February 01, 2008 Issue of MM+M - Medical Marketing and Media
