Drug companies who sell testosterone supplements will be required to warn patients that the products may increase the risk for heart attacks and strokes, the Food and Drug Administration announced Tuesday.
The agency will require manufacturers of testosterone therapy, available by prescription, to include the warning about potential health risks on product labels.
Men taking testosterone should contact a doctor if they develop symptoms of heart attack or stroke, such as chest pain, shortness of breath, weakness or pain on one side of the body or slurred speech, the FDA said.
A 2014 study in PLOS One found that taking testosterone doubled the risk of heart attack in men over 65 and nearly tripled the risk in younger men with a history of heart disease.
Testosterone is often called the “male hormone” because it causes development of male sex organs, facial hair and other masculine features. Doctors use it to treat the symptoms of hypogonadism, which causes abnormally low testosterone levels. Studies have shown that testosterone can improve sexual function, bone density, lean muscle mass and strength while lowering cholesterol and insulin resistance.
Drug companies also have marketed testosterone directly to consumers, urging aging men to ask their doctors about how to relieve symptoms of low testosterone, or “low T,” such as energy loss, mood changes and reduced sex drive.
Testosterone levels naturally decline as men age. The FDA says there is no evidence that taking testosterone is safe or effective for men experiencing those natural changes.
A 2013 study in JAMA Internal Medicine found that only half of men taking testosterone supplements had been diagnosed with hypogonadism and 25% hadn’t even been tested.
Libby Holman, a spokeswoman for AbbVie, which makes AndroGel testosterone therapy, says the treatments are “an important men’s health topic. AbbVie is committed to our patients and we continue to work with the FDA.”
Urologist Abraham Morgentaler, who treats sexual and reproducitve health issues at Men’s Health Boston, published an analysis last month in the Mayo Clinic Proceedings that found no increase in heart risks for men taking testosterone. In his paper, he noted that the four studies that have linked testosterone to heart problems had significant flaws or limitations.
The FDA’s warning is “bad news for men,” Morgantaler says. “It will make it even more difficult for men suffering from true testosterone deficiency.”
Public Citizen, a consumer group, petitioned the FDA to require a stronger warning — called a “black box” warning — in February 2014. The Canadian Health Agency issued a warning about heart and stroke risks in July. European health officials have opted not to require a warning.
“In the seven and a half months since the Canadian action, approximately 4 million prescriptions have been filled in the U.S.,” said Sidney Wolfe, founder and senior adviser at Public Citizen’s Health Research Group. “Had the FDA made this announcement last summer when the Canadian government acted, it would have reduced the number of U.S. prescriptions for and damage from testosterone, a medication of questionable effectiveness for a large proportion of users and one that increases the risk of heart attacks and strokes.”