FDA Warns about Testosterone Drugs for Men

The Food and Drug Administration (FDA) has issued a warning to doctors about testosterone-boosting drugs for men. The popular treatments have not been established as safe or effective for treating common signs of aging like low libido and fatigue.

The FDA warned that the drugs may increase the risk of heart attack, stroke and other cardiovascular problems, The Associated Press (AP) reports. The agency says drug makers must clarify that their drugs are approved only to treat low testosterone levels caused by disease or injury, not normal aging. The FDA has directed manufacturers to add information to the labels about the potential risk and directed them to conduct a long-term study of the issue.

The FDA safety alert explains that the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. Based on the available evidence from studies and expert input from an FDA Advisory Committee, the agency has concluded that there is a possible increased cardiovascular risk associated with testosterone use.

Because current labeling on the drugs is vague, companies including AbbVie and Eli Lilly have promoted the drugs to millions of otherwise healthy men who simply have lower-than-normal levels of testosterone. The widespread advertising – linking low testosterone to a variety of conditions common to aging men – has pushed sales of testosterone drugs to over $2 billion, according to the AP. Roughly 2.3 million patients filled a prescription for testosterone in 2013, up 77 percent from 2010, according to FDA numbers.

The FDA advises patients using testosterone to seek immediate medical attention if they experience symptoms of a heart attack or stroke, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.