Testosterone Boosting Drugs Should Be Limited: EMA

Amid continuing questions about the potential heart risks with testosterone boosting drugs, such as Androgel, AndroDerm, Axiron, Testim and others, European health regulators are warning that doctors should limit use of the “low T” treatments to men with a verified medical testosterone deficiency, avoiding prescriptions for lifestyle benefits. 

The European Medicines Agency (EMA) issued a statement on the use of testosterone boosters on November 21, indicating that while there is not yet consistent evidence about the risk of heart problems, the drugs should still be used with caution.

The statement came following a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), and is in line with recent findings of an FDA advisory committee convened to evaluate the cardiovascular risks of testosterone boosting drugs.

“The PRAC recommended updating the product information in line with the latest evidence and to provide warnings about those who might be at an increased risk of heart problems,” the statement notes. “The product information should make it clear that testosterone should only be used when an abnormally low level of the hormone has been confirmed by signs and symptoms and appropriate laboratory tests.”

In recent years, amid aggressive direct-to-consumer marketing by the makers of Androgel and other pharmaceutical companies, use of testosterone boosting drugs have increased dramatically, with advertisements encouraging men to speak with their doctor about “low T” drugs if they experience any number of symptoms commonly associated with aging, such as reduced energy levels, weight gain and lack of sex drive.

In September, the FDA’s Bone, Reproductive and urologic Drugs and Drug Safety and Risk Management advisory committees issued similar recommendations those reached by the EMA, calling for restrictions on testosterone drugs to men who suffer from medically provable cases of hypogonadism, which is usually caused by disease or injury to the testicles or certain glands in the brain.

The advisory committees also recommended that the FDA force testosterone drug manufacturers to conduct additional clinical trials to better evaluate the side effects of testosterone boosters and determine whether certain users may face an increased risk of heart attacks, strokes, blood clots or death.

“Testosterone levels naturally fall somewhat with age, but restoration of these levels in healthy older men is not an authorized use of the medicine in the European Union,” according to the EMA statement. “The PRAC further considered that the risks of effects on the heart and circulation, and any potential mechanisms for such effects should continue to be monitored, and information from ongoing studies should be provided as part of the next regular safety review.”

Patients who already suffer from heart, liver, or kidney problems should be taken off testosterone drugs immediately, PRAC recommended, even if the links between testosterone and heart problems are not yet conclusive.

Testosterone Drug Heart Risks

The statement from European drug regulators comes about a year after concerns about potential heart risks with testosterone boosters first emerged, following the publication of research in the Journal of the American Medical Association (JAMA) that found older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events.

The JAMA study was followed by another study published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

Amid increasing concerns about the cardiovascular risks within the medical community, other research has found that the drugs are currently widely over-prescribed, with many individuals receiving testosterone boosters when they have normal levels or without ever having their blood tested.

Over the past year, hundreds of Androgel lawsuits, AndroDerm lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug lawsuits have been filed in courts throughout the U.S., alleging that the drug makers placed their desire for profits before consumers safety by aggressively marketing the use of the drug without thoroughly researching the potential cardiovascular risks.

As the number of complaints filed in U.S. District Courts nationwide has continued to grow, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases in June 2014, centralizing all testosterone litigation before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

The first Androgel lawsuits are expected to go to trial in late 2016, which may help gauge how juries will respond to certain evidence and testimony that could be repeated throughout thousands of cases nationwide if testosterone settlements or another resolution for the litigation is not reached before then.