WASHINGTON (AP) — 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.
The agency says drugmakers must clearly state in their labeling and promotions that the drugs, currently taken by millions of U.S. men, are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Additionally, the FDA cautioned 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 prescribing labels and conduct a long-term study to further examine the issue, the FDA said.
Health officials in Canada issued a similar warning about testosterone risks last July.
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 —> Read More Here