If you are thinking of taking testosterone drugs to boost your libido, you’d better be aware of the increased risks of heart attack or stroke, a federal agency warned.
The Food and Drug Administration is requiring manufacturers of testosterone replacement medicines to update their label to take into account new safety warnings. The decision, announced Tuesday, follows concerns from agency advisers last year about the risks of these medicines.
Testosterone replacement therapies are only supposed to be for men who have low testosterone due to a medical condition such as diabetes. However, the agency found that healthy men with low testosterone levels due to aging are also using the drugs.
Testosterone replacement products have grown into a huge market, especially with an aging U.S. population. Testosterone products have generated billions in sales, with Abbvie’s Androgel leading the charge, with $1 billion in 2013.
Low testosterone in and of itself doesn’t need treatment, but can lead to a decreased sex drive, low energy and other quality-of-life conditions.
But the safety of these drugs being used by men with naturally low testosterone isn’t known, the agency said.
After studying the available evidence, the agency concluded that there is a “possible increased cardiovascular risk associated with testosterone use,” according to a safety alert issued Tuesday. “These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke or death associated with testosterone.”
Testosterone treatments come in different forms such as injections, patches and gels.
The agency also warned physicians to prescribe such products only to people with a legitimate medical condition.
