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.
Endocrine Society Warns of Testosterone Therapy Heart Risks
The Endocrine Society released updated guidance on the risks associated with testosterone therapy in March 2018. An article announcing the release begins with a clear warning: “New scientific evidence has strengthened the case for reserving testosterone therapy for well-documented cases of hypogonadism, a condition where the body does not produce enough testosterone.” The article also specifically confirms that the Endocrine Society’s recommendation against unnecessary use of testosterone therapy “has grown stronger” since the release of its previous guidance in 2010.
Due to the risks associated with testosterone replacement therapy, or “TRT” (including heart attack, stroke, and death as discussed above), the Endocrine Society continues to recommend against the “routine” prescription of TRT for men who are past the age of 65. The Endocrine Society also cautions that testing and treatment should be avoided for healthy men of all ages for whom the risks of TRT are not yet well defined and for whom benefits have not been clearly identified.
According to the Endocrine Society, at this time, all decisions regarding treatment with TRT should be based upon patients’ individual characteristics, the nature and severity of their symptoms, and any risk factors associated with their pre-existing conditions (if any). The Endocrine Society also encourages physicians to have “explicit discussion[s]” with their patients regarding the potential benefits and risks (and the current limited knowledge of those benefits and risks) – particularly patients who are over the age of 65.
In December 2018, Harvard Medical School published an update to its article titled, “Is testosterone therapy safe? Take a breath before you take the plunge.” The updated article warns of a “testosterone trap.” As explained by Harvard endocrinologist and assistant professor Dr. Carl Pallais, who is quoted in the article:
“Men get started on testosterone replacement and they feel better, but then it’s hard to come off of it. On treatment, the body stops making testosterone. Men can often feel a big difference when they stop therapy because their body’s testosterone production has not yet recovered.”
The article goes on to warn that the so-called testosterone trap would not represent as great of a concern if it was clear that testosterone replacement therapy lacked any risk of long-term health complications. However, current research indicates that TRT may expose male patients to risks that, while relatively minor in isolation, could lead to problems down the line. In addition to heart attack, stroke, and death from heart disease, these risks also include a “lingering concern” that testosterone therapy may increase men’s risk of prostate cancer.
In the article, Dr. Pallais says that he often discourages his patients from getting started on testosterone therapy, particularly when their natural testosterone is at a “borderline” level. However, the data suggests that many other doctors – with encouragement from the pharmaceutical companies – are regularly prescribing testosterone therapy to men across all age groups for whom treatment may not only be unnecessary, but also potentially dangerous over the long term.
The Connecticut testosterone medication risks attorneys at Berkowitz Hanna 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.