US Food and Drug Administration (FDA) officials announced today that it would require manufacturers of certain antibiotics to put a prominent "black box" warning on their products detailing a link between the medication and an increased risk of tendon ruptures.
Flouroquinolone antibiotics, a potent class of antibiotics which includes Cipro (manufactured by Bayer) and Levaquin (manufactured by Ortho-McNeil), though valued for their effectiveness against deadly bacteria such as anthrax, have been the subject of intense criticism after it was revealed that patients taking the drugs were prone to tendon ruptures and tendonitis. According to consumer advocacy group Public Citizen, over 400 reports of tendon rupture and nearly 350 reports of tendonitis had surfaced by the end of 2007.
Tendons are rope-like tissues which bind muscles to bones and enable body movement. Serious tendon injuries may require surgery to repair, and may cause permanent disability.
Public Citizen filed a petition nearly two years ago complaining that the FDA needed to do more to warn people of the potential risk associated with taking these antibiotics, a call which was answered only today.
FDA officials said that warnings about possible drug side effects have been provided since the drugs went on the market, and that today's announcement was made to increase public awareness of the situation. They emphasized that tendon damage appeared to be preventable if patients stopped taking the drugs at the first sign of pain or swelling.