Another Study Links Testosterone Therapy to Increased Risk of Heart Attack

FDA Launches New Investigation of Testosterone Treatments

Oklahoma City-area men receiving testosterone replacement therapy should take note of a recent study that links testosterone treatment to an increased risk of heart attack in men below the age of 65 with a history of heart disease.

The study of the medical records of 56,000 men who received testosterone replacement treatments found that among men below 65 with a history of heart disease, the incidence of heart attacks more than doubled within 90 days of their first testosterone prescriptions.

“Among younger men [<65 years] with a history of heart disease, we observed a two to three-fold increased risk of MI [myocardial infarction, i.e., heart attack] in the 90 days following an initial testosterone prescription,” the study said. The study also noted that “no excess risk [was found] in younger men without such a history.”

Among men 65 years and older, the study found that the incidence of heart attacks during the 90-day period doubled for all men, regardless of heart disease. However, only 7,100 (13%) of the 56,000 men whose records were analyzed were in the older age group.

“The evidence supports an association between testosterone therapy and risk of serious, adverse cardiovascular-related events, including non-fatal myocardial infarction,” the study concluded. “In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT [testosterone treatment] prescription is substantially increased.”

Researcher-author William Finkle said that he theorizes that testosterone promotes blood clotting.

FDA Launches Investigation

Two days after the research study was published, the U.S. Food and Drug Administration (FDA) announced on Jan. 31 that it has launched an investigation of the association of testosterone replacement treatments with an increased risk of heart attack, stroke and death.

The FDA said its investigation was prompted by the newly release study and by a similar study released in November.

The FDA said in its announcement that it had not confirmed the increased risk suggested by the studies and that it was not advising patients to discontinue testosterone treatments. However, the FDA did warn medical providers to weigh the benefits of testosterone treatment against “the potential risks of treatment.”

What About Men with No Heart Disease?

The big question unanswered by the recent study is how the findings relate to men with no history of heart disease. The study noted that “no excess risk [was found] in younger men without such a history [of heart disease].” However, Finkle also said, “We don’t have enough evidence to say testosterone supplements in men under age 65 without heart disease are safe.”

One critic of the study pointed out that the medical records analyzed provide no information about why testosterone was prescribed to the patients. Were all of the testosterone patients in the study accurately diagnosed with “low T” before receiving the prescriptions or were prescriptions made for other reasons that may influence the results?

The critic also pointed out that the study did not conclusively answer whether it was testosterone treatments that increased the risk of heart attack, or whether the diagnosis of low testosterone itself is the crucial variable.

The study’s authors called for clinical trials to conclusively measure the benefits and risks of testosterone therapy. They also advised medical providers “to include serious cardiovascular events in their discussions with patients of potential risks, particularly for men with existing cardiovascular disease.”

The study is available fee in its entirety online at PLOS One, the online journal of the Public Library of Science.

For More Information

For more information about testosterone treatments and your legal rights if you have experienced harms or losses after receiving testosterone treatments, see “Testosterone Replacement Therapies, Testosterone Treatments” on this website.

If you or a loved one has experienced heart attack, stroke, infertility or death after receiving a testosterone replacement therapy, you should know your legal rights. For a free, confidential consultation, contact Hasbrook & Hasbrook by telephone (866-416-4737), email (cth@hasbrooklaw.com) or use our Contact Form.