FDA Investigates Heart Risks Of Testosterone Products

(RTTNews) - The U.S. Food and Drug Administration said on Friday it is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products for the condition widely called "low-T."

FDA said it is monitoring the risk from the testosterone drugs and decided to reassess this safety issue is based on the recent publication of two studies that suggest an increased risk of heart attacks among groups of men prescribed testosterone therapy.

The FDA said it has not concluded that testosterone increases the risk of stroke, heart attack, or death. But FDA said it is providing an alert while it continues to evaluate the information from the studies and other available data and will communicate final conclusions and recommendations when the evaluation is complete.

Treatments include Axiron, a topical solution applied under men's arms from Eli Lilly & Co. (LLY), which is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone a topical solution applied under men's arms from Eli Lilly & Co. (LLY), and AbbVie Inc. (ABBV)'s AndroGel, which is applied on shoulders and upper arms.

Testosterone is a hormone essential to the development of male growth and masculine characteristics. The products take the form of gels, transdermal patches, material applied to the upper gum or inner cheek, and injection.

In November, a new study has found that men with elevated levels of testosterone have a higher mortality rate than those with average levels. In the study, conducted at the University of Western Australia, researchers measured the testosterone and DHT levels of 3,690 men aged between 70 to 89 in Perth over a three-year period. They then compared their survival rates in December 2010 in correlation to their levels of testosterone. They found that, while men with the lowest testosterone rates had the highest mortality rates, the second-highest mortality rates were shown in men with the highest testosterone rates.

Another study published in the Journal of the American Medical Association in November found an approximately 30% increased risk of death, heart attack or ischemic stroke—those caused by artery blockage—in men treated with testosterone compared with those who didn't receive it. Dr. Michael Ho of the Department of Veterans Affairs in Colorado called the link "an association" that is "not causal," but said that it presented evidence of some risk.