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FDA committee to discuss
adverse effects of testosterone products
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[July 18, 2014]
(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.
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 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)
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