The FDA is currently investigating the risk of heart attack, stroke and death among individuals using a form of testosterone therapy treatment. The FDA made it clear that testosterone products are approved “only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.”
Now, according to an article in the Herald Tribune, some critics find the testosterone therapy treatment “trend [is] reminiscent of another hormonal regimen with a sexy allure,” –hormone replacement therapy in women.
The National Heart, Lung and Blood Institute (NHLBI) conducted a clinical trial to find the benefits and risks of the combination of estrogen and progestin in “healthy menopausal women” between the ages of 50 and 79 years old. The trial was a component of the Women’s Health Initiative (WHI). Researchers wanted to find the “effect of estrogen plus progestin on the prevention of heart disease and hip fractures, and any associated change in risk for breast and colon cancer.”
The study found an increase in risk for strokes, heart attacks, blood clots, breast cancer, and cardiovascular disease. It found a decrease in hip fractures, total fractures, and colorectal cancer. The trial was stopped early due to the findings.
The acting director of the WHI at the time made it clear that these risks to an “individual woman can be low, but the risk to the population at large can be great.”
Estrogen is the main sex hormone in women. Progestin, also known as progesterone, is produced by the ovaries during menstruation. Progestin is combined with estrogen for use as a hormone replacement therapy.
Endocrine Society Calls for Trials to Determine Risk and Benefit of Testosterone Therapy
On February 7th, 2014 the Endocrine Society called for large scale trials to determine the risks and benefits of testosterone therapy treatment. In a statement, the Society argues that a “standardized monitoring system” should be in place with any form of testosterone therapy treatment.
The Public Citizen Group is also calling for action, this time from the FDA. In a petition released in February 2014, the consumer advocacy group asked for several changes, including a “black box warning” on all testosterone therapy treatment.
The FDA stated it has not “concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”
Only a doctor can determine if you need a form of testosterone therapy treatment. You should never stop or start taking any form of testosterone therapy treatment unless instructed to do so by your physician.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.