According to the Endocrine Society, older men who are prescribed testosterone replacement therapy to treat symptoms of low T such as decreased muscle or bone mass, fatigue or low libido should be warned about the possible risk of heart attack and other heart-related problems.
The statement issued by the Endocrine Society follows an announcement from the U.S. Food and Drug Administration (FDA) revealing its plans to review the safety of testosterone replacement therapy. Both agencies are basing their announcements on results from two recent studies that suggest testosterone therapy may increase the risk for heart side effects in some men.
Testosterone therapy products have generated billions of dollars in sales due to a marketing strategy geared towards men in their 40s, 50s and 60s who are experiencing symptoms of low-T due to normal aging. However, testosterone gels, patches and injections have only been FDA approved to treat low testosterone levels in men with hypogonadism, a condition in which the testicles don’t produce enough testosterone.
“Testosterone isn’t approved for age-related conditions and age-related decline in testosterone levels,” said Endocrine Society statement co-author Dr. Shalender Bhasin of Harvard Medical School in Boston.
Also in the statement, the Endocrine Society shared its concerns about jumping on the testosterone bandwagon before the appropriate trials are conducted to determine the benefits and risks.
“Until more information on the risks of testosterone becomes available, older men who have pre-existing heart disease should be particularly careful about testosterone,” Bhasin said.
Results from a PLOS ONE study were published last month, igniting concerns over heart risks. According to the study, men with a history of heart disease nearly doubled their risk of heart attack within the first 90 days of taking testosterone. Another study that evaluated male patients from the Veterans Affairs system suggests there is a link between testosterone replacement therapy and heart attack, stroke and death.
Results from the studies have raised concerns about the heart risks in men of all ages taking testosterone therapy, not just those over the age 65. The FDA said men who are currently taking testosterone should not stop taking it without consulting their physicians.
The Connecticut personal injury lawyers at Berkowitz and Hanna LLC have taken a special interest in testosterone therapy side effects and are available to investigate potential testosterone therapy lawsuits. To find out if you qualify to file a lawsuit, contact our firm today.