LEVAQUIN SIDE EFFECTS LINKED TO TENDON RUPTURES

The FDA has ordered a ‘black box’ warning to be placed on Levaquin informing patients of increased risk of tendon ruptures most commonly in the Achilles tendon. Reports indicate that the risk of tendon ruptures may be increased when Levaquin is used in combination with steroid medications especially in the elderly.

Background:

Levaquin, manufactured by Ortho-McNeil Pharmaceuticals, is in a class of drugs called quinolones and is prescribed to treat serious cases of bacterial infections affecting the lungs, skin and urinary tract. Levaquin, only available by prescription, works by killing bacteria or limiting its growth allowing the body to fight the infection. Levaquin is available in tablet or injection form and was approved by the FDA in 1997.

Levaquin use has been linked to tendon injuries and ruptures during and after therapy; these injuries appear to occur more frequently in older patients. The danger of ruptures is considered even greater when combined with any corticosteroid steroid medications such as prednisone. The Achilles tendon is most frequently associated to the Levaquin induced ruptures, however Levaquin has also been linked to tendon ruptures in the shoulder, biceps, hand, and thumb. Patients should consult their doctor if they experience pain or inflammation of the tendons while on Levaquin or if they are taking a steroid medication while on the antibiotic.

Between November 1997 and the end of December 2005, 794 cases of quinolone-associated tendon rupture, tendonitis and other tendon disorders were reported to the FDA. Of those, 175 cases of tendon rupture occurred between 2003 and 2005. According to FDA estimates, these cases may make up only about 10 percent of all adverse events related to the use of these antibiotics.