More Specialists Question Safety of Testosterone Therapy for Older Men

MONDAY, Feb. 17, 2014 (HealthDay News) -- Following the recent announcement from the U.S. Food and Drug Administration about the potential hazards of using testosterone supplements in older men, another group of experts is raising concerns about the popular treatments.

In a statement, specialists in hormonal therapy at the Endocrine Society said the risks and benefits of testosterone supplements for older men with age-related declines in testosterone levels must be investigated more carefully.

Older men considering such regimens should be warned about the possible risks, particularly heart-related events such as heart attack and stroke, the group said.

The Endocrine Society issued the warning after three recent studies revealed testosterone may not be safe for older men with a history of heart disease. The studies found these men had more heart-related events than men not on testosterone therapy.

For example, in one study published recently in the journal PLoS One, an increased risk of heart attack was found in men younger than 65 with a history of heart disease, and in older men even if they didn't have a history of the disease.

Testosterone therapy has been widely advertised as a way to help aging men improve low sex drive and reclaim diminished energy, and use of the supplements is on the increase. Although the FDA approved testosterone therapy for the treatment of diseases involving the testes, pituitary and hypothalamus, it has not been approved for treating age-related declines in testosterone levels.

Earlier this month, the FDA announced it is "investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products," based on the recent studies.

The U.S. National Institute on Aging is also expected to release the results of research on the safety of testosterone. The study involved roughly 800 older men with low testosterone and symptoms associated with this condition, such as sexual and physical dysfunction. Since the men's heart health was carefully monitored, the research is expected to shed more light on the safety of testosterone therapy.

The Endocrine Society added that more large, randomized controlled studies are needed to investigate the risks and benefits of the treatment for older men. Meanwhile, the group advised that middle-aged and older men who are thinking about using testosterone therapy to treat age-related declines in this hormone should be warned about the possibility of heart-related side effects.

The group said it is especially important for men who've had a heart attack, stroke or other heart-related event in the past six months to avoid testosterone therapy.

On the other hand, testosterone therapy is safe and effective for the treatment of young men with hypogonadism (testosterone deficiency) that resulted from a disease of the testes, pituitary or hypothalamus. These patients should talk to their doctor before making any changes to their treatment plan.

More information

The American Academy of Family Physicians provides more information on testosterone therapy.

SOURCE: The Endocrine Society, news release, Feb. 7, 2014.