The consumer advocacy group Public Citizen said drugs used to treat low testosterone should have a warning label about the risk of heart attack and cardiac problems.
They petitioned the U.S. Food and Drug Administration to add a black box warning, the most serious possible, to the drugs' product labels.
The FDA responded to this request by saying it had not concluded that testosterone in fact does increase heart problems. But this answer was not sufficient in Dr. Sidney Wolfe's eyes, the senior advisor at Public Citizen's health group, who described their statement as "reckless" and "a betrayal of the FDA's role as an agency in the U.S. Public Health Service."
"At the current rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country," Wolfe told Reuters. "Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks."
The group believes the evidence showing their relationship is obvious, and growing. According to Public Citizen, the higher risk of heart attacks and other cardiac problems due to testosterone drug use is supported by a recent published analysis of 27 studies dating back as far as 20 years.
They note that of the 27 studies, the 14 that did show a "highly significant" increased risk were not funded by the pharmaceutical companies, while the rest, which showed no increased cardiovascular risk, were.
After another study from the journal PLOS ONE showed men over 65 years old had a two-fold increase in heart attack risk within 90 days of filling a prescription for a testosterone drug, the FDA issued an alert. They began investigating the risk of stroke, heart attack and death in men taking testosterone drugs based on two other studies suggesting the cardiac risk.
"It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks," Wolfe said.
