Stronger warnings needed about

Brand name medicines appear in green; generic medicines appear in red.

Stronger warnings needed about
tendon rupture when taking certain antibiotics

On July 8, 2008, the US Food and Drug Administration (FDA) notified drug companies that stronger warnings are needed about the risk of tendinitis and tendon rupture when taking certain antibiotics. Tendinitis is a painful swelling of a tendon that affects its normal smooth gliding motion during movement. In some cases, these tendons can tear, requiring surgery to reconnect them. The type of antibiotics that can cause this serious side effect are called fluoroquinolones (see the Table below). Tendon rupture can occur during or even after taking these antibiotics. The tendons most frequently affected are in the shoulder, hand, and back of the heel (Achilles tendon), although other tendons can be involved. The risk of developing tendinitis and tendon rupture is higher in people older than 60 years, in those taking steroids, and in kidney, heart, and lung transplant patients. The FDA recently reviewed all available reports of this injury and confirmed the increased risk of tendinitis and tendon rupture when taking fluoroquinolones. The FDA also found that, despite current warnings about this problem, large numbers of tendon-related events continue to be reported. Now, the FDA is requiring a much stronger warning—called a Boxed Warning—to be prominently displayed in the information available to doctors and other healthcare providers. They are also requiring companies to create a Medication Guide for consumers who take these medicines, alerting them to this risk. People experiencing pain and swelling of a tendon or tendon rupture should stop taking their fluoroquinolone medicine and immediately contact their doctor to switch to another antibiotic. They should avoid exercise and rest the affected area at the first sign of tendon pain or swelling until tendinitis or tendon rupture has been ruled out. For more information, visit the FDA website at: www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm

Fluoroquinolones That Can Cause Tendinitis and Tendon Rupture*
Cipro (ciprofloxacin)
Cipro XR and Proquin XR (ciprofloxacin extended release)
Factive (gemifloxacin)
Levaquin (levofloxacin)
Avelox (moxifloxacin)
Noroxin (norfloxacin)
Floxin (ofloxacin)
*The warning does not apply to fluoroquinolone eye and ear drops.