Antibiotics To Get Warnings Over Tendon Damage

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Antibiotics To Get Warnings Over Tendon Damage 95 Comments By Ed Silverman // July 8th, 2008 // 1:57 pmThe FDA wants to add Black Box warnings to several antibiotics used to treat bacterial infections, including Bayer’s Cipro and Johnson & Johnson’s Levaquin, over concerns the meds cause tendonitis and tendon rupture. The move comes six months after Public Citizen sued the agency to require the warnings on the drug labels.The antibiotics are in a class known as fluoroquinolones, which are sold by various drugmakers under different brand names, and currently carry warnings about the risk of tendon ruptures, although not the Black Box that is the most severe alert to be required by the FDA. Here is the agency statement, which notes the risks are greatest in those over 60 years old; kidney, heart, and lung transplant recipients, and when used in conjunction with steroids.An unspecified number of serious reports of tendonitis and tendon rupture continue to increase with use of the drugs, according to the agency, which adds that the often involve the Achilles tendon, but also include ruptures of the shoulder, hand, biceps, and thumbs. As a result, the FDA wants the drugmakers to create medication guides to be given to patients. UPDATE: In a statement , Sid Wolfe of Public Citizen says the FDA isn’t going far enough. “The FDA is silent on our request that it also send a warning letter to physicians clearly describing possible adverse reactions, such as tendon pain, so that patients can be switched to alternative treatments before tendons rupture.“We are troubled that the FDA is not doing everything within its power to prevent more people from needlessly suffering disabling tendon ruptures. Nothing could be simpler and more effective than a letter to doctors in addition to what the FDA has proposed.”http://www.pharmalot.com/2008/07/antibiotics-to-get-warnings-over-tendon-damage/