Low T Drug Heart Risks Being Reviewed By European Medicines Agency

European drug regulators have also launched an investigation into the heart risks of low testosterone drugs, following recent studies that suggest certain men may face an increased risk of heart attacks, strokes and death.  

On April 11, the European Medicines Agency (EMA) announced that it is reviewing the safety of all drugs that contain testosterone, such as Androgel, Testim, Androderm and other treatments for “Low T”. The risk of heart attacks and other side effects of the drugs are already under review in the U.S. by the FDA.

“The safety concerns were raised following the recent publication of a study suggesting that the use of testosterone increases the risk of myocardial infarction (heart attack) in men aged over 65 years,” the EMA announced in a press release,” as well as in younger men with pre-existing heart disease.”

Concerns about the potential Low T drug heart risks first gained widespread attention following a study published in the Journal of the American Medical Association (JAMA) in November 2013, which found that Low T gels, patches and other treatments may increase the risk of heart attacks, strokes and death among older men with certain pre-existing heart conditions.

The JAMA study was followed by a report published by the medical journal PLoSOne in January 2014, which found that Low T drugs may double the risk of heart attack for young men with heart disease as well as for men age 65 and older who had no prior heart problems. The researchers estimated that for every 1,000 men over the age of 65 who uses AndroGel or another low testosterone treatment, 11.52 may suffer a heart attack. That compares to only 5.27 men per 1,000 who do not use testosterone.

The FDA is currently investigating the potential heart side effects of testosterone therapy, indicating in January 214 that it will re-evaluate the safety of the popular medications following the heart concerns raised by these recent studies.

Amid concerns about the overuse of Low T drugs, the U.S. drug regulators indicated at that time that testosterone replacement therapy is only approved for use among men who have diagnosed low testosterone levels in conjunction with an associated medical condition, such as hypogonadism.

The EMA review came at the request of the member state of Estonia, and is being conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which evaluates drug safety issues. Following its review, PRAC will give recommendations on what, if anything, the EMA should do about the drugs.

Over the past decade, use of testosterone replacement therapy among men in the U.S. has increased five fold, largely driven by aggressive marketing campaigns by the manufacturers of AndroGel and other products, which have encouraged men to seek treatment for Low T if they experience any number of generic symptoms typically associated with aging, such as lack of energy, weight gain or muscle loss.

In the United States, a growing number of men are now pursuing potential AndroGel lawsuits, Testim lawsuits, Axiron lawsuits and other Low T drug lawsuits, claiming that the drug manufacturers failed to adequately warn men and the medical community about the risk of heart attacks, strokes, blood clots and other injuries.

Last month, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation, seeking to consolidate and centralize all Androgel cases filed throughout the federal court system before one judge. There are currently about 38 cases pending over Androgel heart problems, but many estimates suggest that there will ultimately be several thousand lawsuits included in the Low T drug litigation.