The European Medicines Agency (EMA) is reviewing the cardiovascular risks of testosterone drugs, MedPage Today reports. Like the U.S. Food and Drug Administration (FDA) the agency is basing its investigation on two recent studies showing that the drugs are associated with a higher risk of heart attack and cardiovascular death. The review was prompted by the Estonian State Agency of Medicines and will be conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).
The most recent study, published January in PLoS One, showed that testosterone therapy increased the risk of heart attack in older men and younger men who had a pre-existing heart condition. In November, the Journal of the American Medical Association (JAMA) published a study linking testosterone therapy to an increased risk of stroke, heart attack and death.
The FDA announced its review in late January. The agency pointed out that that testosterone drugs are only approved for men who have low levels of testosterone due to a medical condition. In recent years, sales of testosterone medications have been on the rise, largely due to drug companies who tout testosterone as a way to treat “Low-T”, which can manifest as lower sex drive or loss of energy. The FDA has not approved testosterone drugs to treat “Low-T”.
Public Citizen, a consumer advocacy group, petitioned for the FDA to add a “black box” warning to the drugs’ label in February. The black box warning is the agency’s most serious warning. Public Citizen said that its petition was based on mounting evidence linking testosterone to cardiac risks since 2010, in addition to a recent analysis of 27 studies over the course of at least two decades, according to Reuters.
A growing body of evidence suggests “Low-T” drugs are associated with pulmonary embolism, deep vein thrombosis (DVT), stroke, heart attack and other cardiovascular injuries, and death. Since the FDA launched its investigation there have been mounting lawsuits alleging the drugs caused heart problems. Four lawsuits were filed over the testosterone medication AndroGel. The suits, which were filed in the U.S. District Court, Northern District of Illinois, alleging that AndroGel caused the men to suffer from heart attacks, heart failure and stroke; none of the plaintiffs had a prior history of heart disease.