Washington: The Food and Drug Administration is warning doctors against the overuse of estosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for treating common signs of aging like low libido and fatigue.
The agency says drugmakers must clarify that their drugs, currently taken by millions of US men, are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Additionally, the FDA warned that the drugs may increase the risk of heart attack, stroke and other cardiovascular problems.
Drugmakers must add information about that potential risk to their warning labels and conduct a long-term study to examine the issue, the FDA said.
The federal rebuke follows years of industry marketing for new pills, patches, gels 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 ailments common to aging men, including sexual problems and low mood.