The Food and Drug Administration (FDA) 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.
Dr. Sidney Wolfe of Public Citizen says “there’s been a very successful advertising campaign to make men feel that whatever their problem is, the answer is to buy more testosterone.” 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.
Current labeling on the drugs is vague enough that companies have promoted them to millions of otherwise healthy men who simply have lower-than-normal levels of testosterone. “The benefits and safety of this use have not been established,” the FDA said in a statement.
The FDA began reviewing the safety of testosterone drugs in January 2014 after two federal studies associated them with increased rates of heart attack, stroke and other serious problems. Companies sell prescription testosterone in a variety of forms. The market leader, Androgel, is a gel applied to the shoulders and arms. Lilly’s Axiron is a solution that rolls on like deodorant. Endo Pharmaceuticals sells a long-acting injectable testosterone as Aveed. Our firm is handling injury claims related to these medications. If you have questions contact Matt Teague, a lawyer in our firm’s Mass Torts Section, at Matt.Teague@beasleyallen.com.
Source: Matthew Perrone, AP Health Writer
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