Last week the U.S. Food and Drug Administration said it has begun investigating the risk of stroke, heart attack and death in men taking prescription testosterone drugs.
The announcement came on the heels of two recent two studies that suggested an increased risk of heart attacks in men who take testosterone, a hormone produced in the testicles that is responsible for maintaining muscle bulk, bone growth and sexual function, the FDA said. The FDA said it has not concluded that testosterone increases the risk of cardiac events but said it is issuing an alert “while we continue to evaluate the information from these studies and other available data.”
The FDA's action comes after the publication of a new study in the journal PLOS ONE, showing that men over the age of 65 had a two-fold increase in the risk of heart attack within 90 days of filling an initial prescription for a testosterone drug. Among younger men under the age of 65 with a history of heart disease, there was a two- to three-fold increased risk of heart attack, though there was no increased risk in younger men without a history of heart disease. In older men the increased risk was seen whether or not they had a previous heart disease history.
The study, which analyzed 55,593 patients in a large health-care database, echoed the results of a much smaller study published in November in the Journal of the American Medical Association which found that older men, many with underlying heart disease, had a 30 percent increased chance of death, heart attack and stroke after taking testosterone therapy.
Symptoms of low testosterone, or “Low T” as it is sometimes called in advertisements, can include loss of libido, depression, decreased muscle mass and fatigue.
The market for testosterone treatments currently include skin patches, short-acting injections and topical gels. AbbVie Inc's AndroGel, a treatment for hypogonadism and the market leader, generated sales in 2012 of $1.2 billion. Testosterone therapy is only approved by the FDA for men who lack or have low testosterone in conjunction with an associated medical condition, such as a genetic failure of the testicles to produce testosterone, or as a result of chemotherapy.
The Locks Law Firm is investigating cases related to the use of these products and is accepting referrals of cases of men who have utilized testosterone patches, short acting injections and/or topical gels and have suffered a heart attack, stroke, pulmonary embolism or other vascular injury. If you have been contacted by a man who may have been injured by these products, please contact us.