FDA calls for tighter controls over testosterone replacement therapies

An advisory panel of the US Food and Drug Administration has voted to tighten use of testosterone replacement drugs.

On Wednesday the panel voted 20-1 to restrict the use of testosterone replacement therapies to people who have low testosterone because of a medical condition. It will require drug makers to assess the risk of side effects such as heart attack and stroke.

It added that there is little evidence to suggest that testosterone replacement therapy effectively treats men who naturally have drops in the hormone as they age. The increase in use of these therapies in men with age-related low testosterone helped raised the use of testosterone replacement therapies by 65% between 2009 and 2013. Some 2.3 million men received a prescription for testosterone in 2013, up from 1.3 million in 2010.