The European Medicines Agency (EMA) is reviewing the safety of testosterone therapy after studies showed the treatment increases the risk of strokes, heart attacks and death. The announcement comes three months after the U.S. Food and Drug Administration (FDA) launched a similar investigation into the drugs.
Testosterone supplements are prescription medications given to men with low testosterone levels. The drugs are used to treat symptoms of “Low T” such as fatigue, muscle loss, weight gain and low sex drive. The drugs are available in capsules, implants for under the skin, patches or topical gels. Brand names include Testim, Androgel and Axiron.
Sales of testosterone drugs have skyrocketed in recent years, especially in the United States, thanks to heavy advertising campaigns encouraging men to ask their doctors if they could be candidates for testosterone therapy.
However, emerging data from recent studies shows using the drugs may be risky. One study suggested that testosterone therapy increases the risk of heart attack in older men as well as in younger men with cardiovascular disease.
The FDA says that it will report its findings from the investigation and any recommendation once its review is complete. The EMA says following its review, the agency will issue an opinion on whether marketing authorizations should be maintained, changed, suspended or withdrawn across the 28-nation bloc.
Attorneys with Beasley Allen Law Firm are currently investigating cases of heart attack, stroke or death in men while using testosterone replacement products.