The Food and Drug Administration is warning doctors against over-prescribing testosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for common age-related issues like low libido and fatigue.
Testosterone supplements may increase the risk of heart attack, stroke and other heart problems, FDA said. Drugmakers must add information about that potential risk to their prescribing labels and conduct a long-term study to further examine the issue, the FDA said.
The agency says drugmakers must clearly state in their labeling and promotions that the drugs, currently taken by millions of U.S. men to the tune of $2 billion, are only approved to treat low testosterone levels caused by disease or injury, not normal aging.
The FDA action follows years of industry marketing for new gels, patches and injections that promise relief from low testosterone or "Low-T." Promotions from AbbVie, Eli Lilly & Co. and others link the condition to a variety of common ailments in aging men, including sexual problems and low mood.
"There's been a very successful advertising campaign to make men feel that whatever their problem is, the answer is to buy more testosterone," said Dr. Sidney Wolfe of Public Citizen. The consumer advocacy group petitioned the FDA last February to add a boxed warning -- the most serious type-- to testosterone drugs about heart risks. But the FDA rejected the petition in July, saying there was "insufficient evidence" for such a warning.