Testosterone Therapy Risks Require Large Scale Studies: Group

A group of endocrinology experts are calling for a large-scale scientific study to help doctors better understand the potential risk of heart attacks and other injuries that may be caused by side effects of testosterone replacement therapy (TRT), including popular medications like AndroGel, Testim, AndroDerm and others. 

On February 7, the Endocrine Society issued a statement (PDF) warning about the serious concerns raised by two recent studies that suggested users of testosterone treatments may face cardiovascular risks, urging doctors to follow the Society’s clinical practice guidelines (PDF) on the appropriate prescribing of testosterone.

In response to mounting concerns about the heart risks from AndroGel and other testosterone treatments, the Endocrine Society is calling for a large, randomized trial to accurately define the risks and make sure that patients are better informed about the potential side effects. However, many consumers are questioning why the manufacturers of these blockbuster medications have not previously conducted such studies.

“Large scale, prospective, randomized controlled trials are needed to determine the risks and benefits of testosterone therapy in older men with age-related decline in testosterone levels,” the Society states. “Until evidence from large randomized trials becomes available, the Endocrine Society believes that patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels and symptoms.”

The Endocrine society urges doctors and patients to discuss the risk and benefits, particularly in patients who have pre-existing heart disease.

Testosterone Heart Risks

On January 31, the FDA announced that it is investigating the potential testosterone therapy risks. In a safety announcement issued by the agency, the FDA indicated that the products were never approved for any use other than to treat men who have a medical condition that’s causing them to have lower testosterone than normal, such as hypogonadism.

In November 2013, a study published in the Journal of the American Medical Association found that testosterone drug side effects were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by another study released late last month by the medical journal PLOSOne, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

While many men are just now learning about the link between heart problems and Androgel or other testosterone treatments, many critics have suggested that the manufacturers knew or should have known about the risk and conducted additional studies. In 2009, a study involving more than 200 older, frail men was stopped early after researchers found that individuals receiving testosterone treatments had a spike in heart attacks.

A growing number of men who suffered a heart attack or stroke in recent years are now considering potential AndroGel lawsuits and other testosterone injury lawsuits, alleging that they may have avoided serious health problems if information had been disclosed to consumers and the medical community.