EU regulators weigh in on hotly debated testosterone, heart attack link
- Over the last several years, drug companies have aggressively marketed testosterone products, claiming that using testosterone leads to an increases sex drive, improved mood, and decreased fatigue. The strategy's worked: use of testosterone products doubled between 2010 and 2013.
- The EMA convened a committee to study the health effects after numerous reports of a link between testosterone use and heart attack. Though there is plenty of evidence confirming this link, there is also evidence refuting it.
- In the U.S., a similar data review has led to an FDA panel recommendation for labeling that dilutes some of the most optimistic claims associated with testosterone products, such as mentioning the fact that these drugs have not been proven to reverse the effects of aging.
Marketing efforts around various testosterone-based drugs have been wildly successful in the last four years in both the U.S. and in the EU. However, concerns about cardiovascular risk have led to intense regulatory scrutiny.
One study published in the Journal of the American Medical Association (JAMA) evaluated use of testosterone is a study involving almost 9,000 veterans. In this study, testosterone use increased the risk of heart attack and stroke by 29%. A separate study found that in men under 65 with a history of heart disease, CVD risk doubled during the first three months after initiating therapy. Still, other large studies show no associated risk.
Product labeling is being updated in the EMA to suggest that men should be tested and deemed testosterone insufficient before initiating therapy; however, the EMA is not going so far as to cite the risk of heart attack when using testosterone products. The FDA also has yet to take that step, though it is under pressure to add more serious warnings.