Common Antibiotic to Get Extra Warnings

(July 10, 2008) - A relatively common antibiotic group (Read about "Antibiotics") is getting an extra warning added to its label on side effects. Fluoroquinolone antimicrobial drugs have been implicated in an increased risk of tendinitis and tendon rupture. (Read about "Tendinitis & Bursitis")

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

Cipro became well-known as an antibiotic during the anthrax scare a few years ago. (Read about "Biological Health Threats")

"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 U.S. Food and Drug Administration (FDA) says it has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysis reconfirms that 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.

FDA says 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. (Read about "Transplants") Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their healthcare 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.