July 8, 2008  

FDA Must Do More to Warn Patients Taking Flouroquinolone Antibiotics of Possible Tendon Ruptures

Statement of Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen

 Today’s announcement by the Food and Drug Administration (FDA) that it will require a “black box” warning on fluoroquinolone antibiotics, as well as an FDA-approved medication guide to be dispensed when prescriptions are filled, accomplishes two of the three steps Public Citizen has urged the agency to take for nearly two years.

 While we are pleased the agency has moved forward on part of the petition we filed in August 2006, there is still more that the FDA must do to make doctors and, indirectly, patients aware that fluoroquinolone antibiotics, such as Cipro, Levaquin and others, can cause serious tendon ruptures and tendinitis.

The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture.

 We are troubled that the FDA is not doing everything within its power to prevent more people from needlessly suffering disabling tendon ruptures. Nothing could be simpler and more effective than a letter to doctors in addition to what the FDA has proposed.

 Since Public Citizen filed its petition, more than a hundred cases of tendon ruptures have been reported to the FDA that might have been prevented had the FDA acted with more urgency. From November 1997 through December 2007, there have been 407 reported cases of tendon rupture and 341 cases of tendinitis in patients using fluoroquinolone antibiotics. Because only a small fraction of cases are typically reported to the FDA, the actual number of ruptures and other tendon injuries attributable to the antibiotic is much higher.

 Public Citizen sued the FDA in January for not responding to our petition in a timely manner. There is no excuse for the FDA not fully complying with our petition. No one in the medical community disputes that these antibiotics can cause tendon ruptures, and the FDA has not learned anything new since we filed our petition and lawsuit. It shouldn’t require legal action to get the FDA to do its job.

Patients taking fluoroquinolone antibiotics and their doctors need to know the risks they face. Our lawsuit will continue until the FDA determines whether it will require companies to send a warning letter to doctors.

  READ Public Citizen’s lawsuit.