FDA reviewing heart risks of testosterone drugs

The risk of stroke, heart attack and death in men taking testosterone supplements is currently under investigation by the Food and Drug Administration.

The FDA announced last week its investigation into FDA-approved testosterone products was spurred by two recent published studies, both of which suggest “increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”

A group of nine Mercy Health physicians have also published their own research studies on the negative impacts of testosterone use in men with underlying blood clotting disorders, said Dr. Charles Glueck, medical director of the Mercy Health - Cholesterol and Metabolism Center.

Those found with underlying blood clotting disorders who also use testosterone are more likely to get blood clots in their legs, lungs and bones, Glueck said.

“These studies … now tell us when testosterone is prescribed you have to be very careful,” Glueck said. “It puts you at substantially increased risk.”

Andrea Fischer, spokeswoman for the FDA, said testosterone products are FDA-approved only for use in men who have low testosterone levels in connection with an associated medical condition. Those conditions could include failure of the testicles to produce testosterone due to genetic problems or chemotherapy, as well as problems with brain structures that control the production of testosterone, according to the FDA.

“A relatively small number of men need testosterone therapy because for one reason or another that can’t produce testosterone,” Glueck said. “Those men should continue to receive therapy and be screened, we believe, for underlying blood clotting disorders.”

Low testosterone affects roughly 39 percent of men over the age of 45, according to the Urology Care Foundation. The use of testosterone patches, topical gels and creams has increased fivefold from 2000 to 2011.

Today, American men are thought to spend $1.6 billion annually on prescription testosterone supplements.

Glueck said about 4 percent of men over the age of 40 are prescribed testosterone — a hormone essential to the development of male growth and masculine characteristics. Testosterone helps men to maintain bone density, muscle mass, red blood cell production, fat distribution and has some role in sex drive, according to Glueck said.

“Don’t casually prescribe this drug without very careful and exacting diagnostic approaches,” Glueck said. “Testosterone as a recreational drug is a very bad idea.”

The two publications referenced by the FDA were both observational studies of older men about 60-65 years old.

One study, published in November 2013 in the Journal of the American Medical Association, included men in the U.S. Veteran Affairs health system that had low serum testosterone and underlying cardiovascular disease. Some of the men received testosterone treatments, while the rest did not.

The study concluded the men that were prescribed testosterone therapy had a 30 percent increased risk of stroke, heart attack and death, according to the FDA.

The FDA has not made any recommendations yet on the study findings, but has said patients shouldn’t stop taking prescribed testosterone products without first discussing it with their health care provider.

The Associated Press contributed to this report.