WASHINGTON — The Food and Drug Administration is warning doctors against overprescribing testosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for common age-related issues such ase low libido and fatigue.
The agency says drugmakers must state clearly in their labeling and promotions that the drugs, taken by millions of U.S. men, are approved only 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 in July.
