FDA committee to discuss adverse effects of testosterone products

Reuters
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012. REUTERS/Jason Reed

(Reuters) - The U.S. Food and Drug Administration has called an advisory committee meeting on Sept. 17, to discuss the adverse cardiovascular outcomes with the usage of testosterone replacement therapy. The FDA has called for a joint meeting of the bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee. (http://1.usa.gov/1nPA7Qf) In June, the FDA said that all testosterone products on the market should include in their labels a general warning about the risk of blood clots in veins. These treatments are used by men who have low levels of testosterone. Products on the market or about to be launched include AbbVie Inc's AndroGel, Endo International Plc's Aveed and Trimel Pharmaceuticals Corp's Natesto. (Reporting By Amrutha Penumudi in Bangalore; Editing by Savio D'Souza)