FDA Demands Warnings for Cardiovascular Risks on all Prescription Testosterone Low-T Products

Los Angeles, CAThe potential risk for heart attack and stroke associated with prescription testosterone products has prompted the Food and Drug Administration (FDA) to demand new warnings and label changes be made to all prescription “Low T” drugs, such as AndroGel, Axiron, Testim, Depo-Testosterone and other gels, creams patches and injections.

In a statement issued March 3rd, the FDA notes that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions." The agency adds “based on the available evidence from published studies and expert input from an Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.”

Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. However, the agency states that it is aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone due to aging.

While a number of studies have shown that treating low testosterone can improve men's sexual function, bone density, strength and lean muscle mass and at the same time lower cholesterol and insulin resistance, the recent JAMA study indicates that the risks outweigh the benefits. Researchers reported that men who used testosterone were 30 percent more likely to have a heart attack or stroke or to die during a three-year period than men with low hormone levels who didn't take the supplements. The study’s 3,000 participants averaged 60 years of age and most of the men (hormone users and non-users) had other health problems including high blood pressure, unhealthy cholesterol and diabetes.