Pharmaceutical

New study raises questions about safety of testosterone replacement therapy

androgel pump 435x435 New study raises questions about safety of testosterone replacement therapyA new study raises questions about the link between testosterone replacement therapy and heart attacks.

Researchers at the University of Texas, Medical Branch at Galveston, studied more than 25,000 men, all Medicare beneficiaries older than 65 who were treated with testosterone injections for up to eight years. These men were compared to about 19,000 men of the same age who did not use testosterone treatments.

Researchers found that testosterone users were not at greater risk of having a heart attack compared to nonusers of testosterone therapy. Researchers did not track strokes, blood clots, dementia or death. The results contradict several other studies that indicate testosterone replacement therapy does increase risk for cardiovascular events.

“Our investigation was motivated by a growing concern, in the U.S. and internationally, that testosterone therapy increases men’s risk for cardiovascular disease, specifically heart attack and stroke,” said Jacques Baillargeon, UTMB associate professor of epidemiology in the Department of Preventive Medicine and Community Health and lead author of the study. “This concern has increased in the last few years based on the results of a clinical trial and two observational studies.”

Last November, the Journal of the American Medical Association (JAMA) revealed that men who used testosterone supplements had a 30 percent increased risk of heart attack, stroke and death compared to men who did not use the drugs. A second study, published in January in the journal PLOS One, found a two-fold increased risk in heart attack among men 64 years of age and older in the first 90 days of testosterone treatment. And, younger men with cardiovascular disease had a two- to three-fold increased risk of heart attack in the first three months of treatment.

A more recent study, published in the Journal of Alzheimer’s Disease, found that testosterone therapy could damage the brain, causing memory loss and cognitive decline, which could lead to dementia or Alzheimer’s disease.

The Food and Drug Administration (FDA) responded by launching an investigation into health risks associated with testosterone replacement therapy. Though the FDA is still reviewing data, last month the agency issued a Safety Announcement saying it was ordering manufacturers of testosterone products to add to the safety labels of the products a new warning for serious and potentially life threatening blood clots.

Makers of testosterone therapies, such as AndroGel, Axiron and Testim, are currently facing hundreds of lawsuits from men and their family members claiming the drug companies did not adequately warn consumers of the serious risks associated with the products.

Source: The University of Texas Medical Branch