Public Citizen Urges FDA to Warn Consumers About Risk of Tendon Rupture Associated With Certain Antibiotics

Public Citizen filed a petition with the Food and Drug Administration (FDA) on August 29 urging that the agency immediately warn consumers about the risks of tendonitis and tendon rupture associated with the use of fluoroquinolone antibiotics, such as ciprofloxacin (CIPRO).

Between November 1997 and the end of December 2005, 794 cases of fluoroquinolone-associated tendon rupture, tendonitis and other tendon disorders were reported to the FDA. Of those, 175 cases of tendon rupture occurred between 2003 and 2005. According to FDA estimates, these cases may make up only about 10 percent of all adverse events related to the use of these antibiotics.

To help protect the public, Public Citizen feels the FDA should add a black box warning, the strongest type of warning the FDA can request, to the professional product labels (package inserts) of all fluoroquinolone antibiotics, alerting health professionals about the risks of using the drugs. A list of fluoroquinolone antibiotics currently marketed in the United States accompanies this article.  

In addition, Public Citizen’s petition asks that a “Dear Doctor Letter” be sent to warn physicians about these potentially serious adverse drug reactions. The full text of the petition is available on the Internet at http://www.citizen.org/publications/release.cfm?ID=7453.

However, consumers rarely see professional product labels and physicians may not pay attention to “Dear Doctor Letters” or to professional product labels. Therefore the petition also asks FDA to require pharmacists to distribute FDA-approved written information, called Medication Guides, informing consumers about the potential tendon damage that can result from these antibiotics and what steps to take if unexplained tendon pain should develop.  

Public Citizen’s petition was written in support of a similar document filed by the Office of the Illinois Attorney General on May 28, 2005  , asking the FDA to add a black box warning to the professional product labels of fluoroquinolones about tendonitis and tendon rupture. More than a year after that document was filed, the Illinois Attorney General still has not received a substantive response from the FDA.

Public Citizen successfully petitioned the FDA 10 years ago, on August 6, 1996  , to add warnings to the professional product labels for all fluoroquinolone antibiotics concerning potential tendon damage. At the time, we thought this would effectively educate physicians and patients about this adverse event.

However, the FDA required only a simple, non-highlighted warning buried in the long list of adverse reactions possible with the fluoroquinolones. This has been grossly inadequate in warning consumers and health professionals about this adverse drug effect.

The language Public Citizen suggests for the black box warning for these drugs accompanies this article.

Rupture of the Achilles tendon that runs from the back of the heel to the calf causes sudden severe pain, difficulty walking, and swelling and bruise formation in the affected area prompting immediate medical attention. Achilles tendon rupture has classically been a sports-related injury. The treatment is either surgery or casting for six to eight weeks followed by months of physical rehabilitation.  Tendonitis causes pain and swelling in the affected tendon and is treated by removing the offending agent, anti-inflammatory medication, rest, and physical rehabilitation.  

What You Can Do
You should stop taking fluoroquinolone antibiotics and immediately contact your physician if you experience pain in any tendon while taking one of these antibiotics.