Tendon Rupture from Antibiotics

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Tendon Rupture, a Little-Known Side Effect of Antibiotics

Here's one more for the long list of tales about how the drugs we take to heal us can end up causing harm: The FDA has announced that it will now require a "boxed warning" (its strongest warning on a label) about the risk of tendonitis and tendon rupture associated with use of fluoroquinolone antibiotics -- such as ciprofloxacin (Cipro) -- along with mandated distribution of a newly detailed medication guide to be dispensed by pharmacies with the drug.

WHAT YOU NEED TO KNOW

Fluoroquinolones such as ciprofloxacin (Cipro and Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin) are commonly prescribed for upper respiratory, gastrointestinal and urinary tract infections (UTIs). FDA-approved labeling for these drugs mention the risk of tendonitis, but clearly public awareness is not widespread as the FDA continues to receive reports of tendon-related adverse events related to them. The FDA has received more than 400 reports of tendon rupture plus more than 1,200 of tendon problems, and, it's possible this represents only the tip of the iceberg since it's suspected that just a small fraction of cases are reported to the FDA.

I spoke with Sidney Wolfe, MD, director of The Health Research Group at Public Citizen, an advocacy group based in Washington, DC, which has been pushing the FDA on this point since 2006. In his view, these requirements are better than none, but far from complete. "This accomplishes two of the three steps we've urged," he said. "We've also requested that the FDA require drug companies to send a warning letter to physicians, clearly describing possible adverse reactions, such as tendon pain, so patients can be switched to alternative treatments before tendons rupture." Many doctors remain unaware of drug warnings like these until they receive such letters, Dr. Wolfe said. He advises consumers to be aware of the risks and attentive to early signs of trouble in order to protect themselves from serious repercussions.

WHO'S AT RISK? Although anyone who takes fluoroquinolone drugs is at risk, the likelihood of having tendon problems is higher if you are over 60, taking steroids (corticosteroids), or are a kidney, heart or lung transplant recipient. Symptoms of tendonitis include pain, swelling, inflammation and tearing, all found most commonly in the Achilles tendon, shoulder or hand. Ruptures can occur without warning (some patients report feeling a "snap" or "pop" soon after starting treatment), but more typically patients feel pain or inflammation for days or weeks before the tendon actually ruptures. Another symptom is easy bruising right after an injury in a tendon area. These problems can occur during or after taking fluoroquinolones -- even months later, according to the FDA.

If you develop tenderness or other such problems, avoid exercising or overuse of the area. Any such symptoms should be immediately reported to your doctor in conjunction with your request to be switched to another antibiotic of a different class. Most serious problems may be avoided if you pay attention to the first signs of trouble.

Source(s):

Sidney Wolfe, MD, Director of The Health Research Group at Public Citizen and editor of www.worstpills.org, in Washington, DC.

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