Consumer Group Urges Cardiac Risk Warnings on Labels of Testosterone Drugs

Drugs to treat low testosterone should carry strong label warnings about the risk of heart attacks and other cardiovascular problems, the consumer advocacy group Public Citizen urges.

Public Citizen petitioned the Food and Drug Administration (FDA) to add its strongest possible warning – a black box warning – to labels on testosterone drugs, Reuters reports. The FDA approved testosterone therapy for men who lack testosterone or have low testosterone in conjunction with an associated medical condition, for example, genetic failure of the testicles to produce testosterone. Loss of libido, depression, decreased muscle mass and fatigue are among the symptoms of low testosterone, but Public Citizen says that nearly 25 percent of men who are prescribed testosterone have not had a blood test to determine if their level is actually low.

Public Citizen’s petition is based on evidence of the risks of heart attacks and other cardiac problems from studies dating to 2010 and from a recent analysis of 27 studies that go back as far as 20 years. Public Citizen says the 27 studies in the analysis diverge on the question of cardiovascular risk. The 14 studies not funded by the pharmaceutical industry showed a “highly significant” increased risk, while the 13 funded by drug companies showed no increased cardiovascular risk, according to Reuters. In January, the FDA issued a safety alert saying it would “reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”

The FDA alert said the agency had not concluded that testosterone does, in fact, increase heart problems. Dr. Sidney Wolfe, senior adviser to Public Citizen’s health group, calls this statement “reckless.” “It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks,” Wolfe says. The FDA issued the alert after PLoS ONE published a study showing that men over 65 had a two-fold increase in the risk of heart attack within 90 days of filling a testosterone prescription. Men under 65 with a history of heart disease showed a two- to threefold increased risk of heart attack; no increased risk was reported for younger men without a history of heart disease, according to Reuters. The increased risk for older men occurred regardless of whether they had a previous history of heart disease.