FDA Warning: Fluoroquinolone Antimicrobial Drugs Increase Risk of Tendinitis and Tendon Rupture

Filed in archive Consumer Alert , News on July 8, 2008

The FDA is requiring a Boxed Warning in the product labeling of fluoroquinolone antimicrobial drugs concerning the increased risk of tendinitis and tendon rupture.

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.

Manufacturers of such antimicrobial drugs have been notified of the FDA requirement.

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. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.

Well...I hope the manufacturers comply and make sure that the said drug class is safe for use. Else, it's the consumer's health that is at stake. But then...aren't we generally at the mercy of the FDA and the drug manufacturers? I'm just saying... i think always been.

Read more from FDA News.

[In Photo: Fluoroquinolone Antibiotics (Milestones in Drug Therapy) (Hardcover)]