Cipro and Tendon Ruptures
Cipro and Tendon Ruptures
In July 2008, a black box warning about tendon ruptures was finally added to the label of the antibiotic Cipro. However, the risk of tendon damage associated with Cipro has been known for well over a decade. It was only after a prominent consumer advocacy group filed a lawsuit against the Food & Drug Administration (FDA) to force the agency to warn the public about Cipro and tendon ruptures that it finally did.
Cipro is a member of the flouroquinolone group of antibiotics, prescribed to treat bacterial infections of the abdomen, bones, urinary tract skin and lower respiratory system. Health officials prescribe Cipro to combat bronchial infections, typhoid fever, prostate gland infections and tuberculosis. Cipro gained notoriety in 2001, when it was used to treat victims of the anthrax attacks.
In 1996 the nonprofit group Public Citizen petitioned the FDA seeking a warning for tendon damage on the label of Cipro and the other flouroquinolone antibiotics. The FDA that year granted the petition, but the warning was buried in the list of possible adverse reactions and proved to be inadequate.
In 2006, Public Citizen again petitioned the FDA, this time seeking the agency’s strongest warning - a “black box” - to highlight Cipro’s association with tendon injuries. At the time, Public Citizen’s review of the FDA’s adverse event database showed 262 reported cases of tendon ruptures, 258 cases of tendonitis and 274 cases of other tendon disorders between November 1997 and Dec. 31, 2005, associated with the fluoroquinolone antibiotics, with 175 of those occurring since the beginning of 2003. Nearly one quarter of the reported tendon ruptures were associated with Cipro.
The FDA never satisfactorily responded to the Public Citizen petition, so in January 2008, the group filed a lawsuit against the agency. At the time the lawsuit was filed, an additional 74 tendon ruptures had been reported to the FDA for a total of 336. Public Citizen said in its complaint that by failing to act upon its 2006 petition, the FDA was violating the Administrative Procedure Act.
In a press release announcing the antibiotic lawsuit, Public Citizen asserted that stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics. “While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The current warning is buried in a long list of possible adverse reactions and is far too easy to miss.”
In July 2008, the FDA finally announced that Cipro and other antibiotics in its class would bear the black box warning sought by Public Citizen. In announcing the black box, the FDA said that Cipro and other fluoroquinolones had been associated with tendonitis and tendon ruptures. The risk is greatest for those over age 60, those on concomitant steroid therapy, and kidney, heart, and lung transplant recipients.
According to the agency, some of the of the reported tendon ruptures occurred without warning, causing the patient to experience a snap or pop soon after starting treatment. That suggests flouroquinolone antibiotics like Cipro may be toxic to some people, the FDA said. But in most cases, patients felt some kind of pain or inflammation for a week or two before they suffered a tendon rupture.
The FDA said that tendinitis and tendon rupture associated with Cipro and similar antibiotics most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, and the thumb have also been reported. Tendon rupture can occur during or after completion of a course of Cipro; although cases occurring up to several months after completion of therapy have been reported.
The FDA warned that Cipro treatment should be stopped if a patient experiences pain or inflammation in a tendon (symptoms that may precede rupture of the tendon), or tendon rupture. Health care professionals were told to advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking Cipro, to avoid exercise and use of the affected area, and to promptly contact their healthcare provider about
