Heart Health Risks Spur Stricter Rules for 'Low T' Meds

Studies have linked medications that boost the male hormone testosterone —normally prescribed for men with “low T” — to higher risk of heart attacks in older men, and in middle-aged men with a history of heart disease.

Now the Food and Drug Administration (FDA) is set to impose stricter limitations on the testosterone drug industry at a time when such medications are considered to be over-prescribed for men who don’t need them. Testosterone usage has quadrupled since the early 2000s for men in their 40s.

An expert panel has recommended that manufacturers of testosterone drugs tighten “indications for use” so they are not prescribed to men who only have problems related to aging, such as lower energy and decreased libido.

Product labels should include stricter language on what health conditions should be treated with these drugs, the panel recommended. The FDA usually follows the advice of such panels.

“The FDA is taking the proper precautions against misuse or overuse of these supplements and the potential risks they pose to men’s heart health,” says cardiologist Theodore Feldman, M.D., medical director of Baptist Health’s wellness and prevention program. “Men who suffer from low testosterone levels are usually at the age when heart disease could already be present. Men should be carefully screened for heart disease risk factors before such medications are prescribed.”

Men at Risk Should Consult Their Doctors
Research on the affects of “low T” drugs indicates that cardiac problems are potential side effects of testosterone gels, patches, pellets and injections. It is especially important for men with heart disease risk factors, including hypertension, diabetes, unhealthy cholesterol levels and a family history of heart disease, to consult their physician.

Makers of testosterone medications are also being urged to conduct more tests on the cardiovascular safety of the supplements, which are commonly available as gels and patches.

It’s natural for testosterone levels to decline as men age, starting after age 30 and continuing throughout life.

Testosterone drugs were prescribed in the past for men with serious medical conditions. But these prescriptions have surged, and testosterone supplements now being taken by more than 2 million American men who suffer from symptoms that are mostly the result of aging, a trend that is alarming the medical community.

FDA Re-evaluating ‘Low T’ Products
If the F.D.A. adopts the panel’s recommendations, as it is expected it will do, the move could sharply reduce the number of men prescribed these medications. It could also mean fewer of those now-pervasive TV commercials promoting medicines for “men with Low T.”

A study published in January tracked about 56,000 (middle-aged and older) men around the country who were prescribed testosterone between 2008 and 2010. The results show that men from this group who were 65 and older had double the rate of heart attacks in the months after starting the drug, as did those younger than 65 with a previous diagnosis of heart disease.

Earlier this year, the FDA said it was re-evaluating the safety of testosterone products as a result of recent studies linking testosterone medications to higher rates of strokes and heart attacks.

“These studies should serve as a reminder for middle-aged men and the elderly to see their doctors regarding the top risk factors, including high-blood pressure, diabetes cholesterol and a family history of heart disease,” Dr. Feldman says. “Proper testosterone levels are important, but underlying heart health issues are often more critical.”