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FDA Wants Black Box Warning on Antibiotics

Tendinitis, other side effects can occur

July 8, 2008

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The U.S. Food and Drug Administration has requested a "black box" warning on certain antibiotics, alerting consumers to the increased risk of tendinitis and tendon rupture but Public Citizen said the agency should have taken the step years ago.

The agency has also determined that it is necessary for manufacturers of the drugs to provide a medication guide to patients about possible side effects.

The antibiotics in question are flouroquinolone drugs, which are powerful antibacterials. Among the best known drugs in that class are Cipro, manufactured by Bayer, and Levaquin, which is produced by Ortho-McNeil.

The FDA has notified the manufacturers of these drugs that a "Risk Evaluation and Mitigation Strategy (REMS)" is necessary to ensure that the benefits of the drug outweigh the risks. The medication guide will be considered to be an element of the REMS.

Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen, noted that his organization had asked the FDA to require the black box warning nearly two years ago.

"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," Wolfe said.

Wolfe said the FDA has not responded to a 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.

Troubled

"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," he said.

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, Wolfe charged.

"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," he said. "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."

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research.

"The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture.

It also demonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in federal law.

The FDA also issued a bulletin to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients.

Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language.

Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary.

Health care professionals should consider the potential benefits and risks for each patient, the FDA said. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.

Lawsuit

Public Citizen sued the FDA in January for not responding to its petition in a timely manner.

"There is no excuse for the FDA not fully complying with our petition," Wolfe said. "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."

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