Thursday, September 18, 2014

FDA Panel Recommends More Study on Testosterone Drugs for 'Low-T' Use

Decision Could Have Implications for Millions of Older Men Taking Testosterone-Replacement Drugs

By Thomas M. Burton, WSJ
Sept. 17, 2014 6:48 p.m. ET

A Food and Drug Administration panel on Wednesday recommended that makers of testosterone-replacement drugs study possible increased risks of heart attack and stroke from the hot-selling products.

The outside panel of experts also voted overwhelmingly that the FDA should come up with language in the products' labels to restrict the intended uses of the drugs, which critics say are overprescribed. The decision could have implications for millions of older men taking the medicines.

At issue are drugs that are supposed to be aimed at men with low levels of testosterone for medical reasons, like genetic causes or chemotherapy. However, the medicines are widely prescribed for older men trying to boost their sex drives or low energy levels.

Among existing products are AndroGel from AbbVie Inc. and Axiron from Eli Lilly & Co. Companies that make the products say they don't condone their use for off-label purposes.

(More here.)


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