Endocrinologists Criticize FDA's Advisory Against Testosterone Replacement Therapy


On May 15th, two members of a panel of doctors cast doubt on a Food and Drug Administration (FDA) advisory recommendation issued in March against testosterone replacement therapy (TRT) for hypogonadism. Medpage Today reports that two prominent endocrinologists are critical of the FDA’s decision, considering it premature. Dr. Sandeep Dhindsa, MD, of the Texas Tech University Health Center and Dr. Susan Davis, PhD, MBBS, of Monash University in Melbourne, Australia both criticized the FDA’s justification of the advisory for being too vague. They also suggested that TRT can ultimately benefit qualified patients despite the risks associated with it. In March, the FDA issued an advisory telling patients to avoid using the therapy for age-related symptoms alone. Testosterone levels naturally decrease in the male body around the age of 30, and the FDA believes there is not enough compelling evidence to verify its effectiveness and safety. However, on a panel at the American Association of Clinical Endocrinologists annual meeting in Nashville, Dhindsa and Davis said the FDA did not provide enough details regarding when hypogonadism (also known as “low testosterone”) is caused by age alone. They point out that the causes of hypogonadism among older men are not fully known, and other factors such as comorbidities and certain medications need to be taken into account. Men who have an “unequivocally low morning serum testosterone concentration” along with symptoms of hypogonadism should all be considered candidates for TRT according to Dhindsa. “Any patient being considered for testosterone replacement therapy should undergo a thorough diagnostic workup,” Dhindsa wrote in a conference press release. “The decision to replace testosterone therapy should be guided by the signs, symptoms, and testosterone concentrations rather than the underlying cause.” Another press release at the conference noted that the associated risks of TRT such as cardiovascular disease aren’t conclusive. “There is no compelling evidence that TRT either increases or decreases cardiovascular risks” and that “testosterone therapy favorably changes many cardiovascular risk factors by decreasing fat mass, increasing muscle mass, and decreasing insulin resistance,” according to the release. If left untreated, low testosterone in men can cause a 33% greater chance of death within the next 18 years of a man’s life than men with normal testosterone levels.

On May 15th, two members of a panel of doctors cast doubt on a Food and Drug Administration (FDA) advisory recommendation issued in March against testosterone replacement therapy (TRT) for hypogonadism.

Medpage Today reports that two prominent endocrinologists are critical of the FDA’s decision, considering it premature. Dr. Sandeep Dhindsa, MD, of the Texas Tech University Health Center and Dr. Susan Davis, PhD, MBBS, of Monash University in Melbourne, Australia both criticized the FDA’s justification of the advisory for being too vague.

They also suggested that TRT can ultimately benefit qualified patients despite the risks associated with it.

In March, the FDA issued an advisory telling patients to avoid using the therapy for age-related symptoms alone. Testosterone levels naturally decrease in the male body around the age of 30, and the FDA believes there is not enough compelling evidence to verify its effectiveness and safety.

However, on a panel at the American Association of Clinical Endocrinologists annual meeting in Nashville, Dhindsa and Davis said the FDA did not provide enough details regarding when hypogonadism (also known as “low testosterone”) is caused by age alone. They point out that the causes of hypogonadism among older men are not fully known, and other factors such as comorbidities and certain medications need to be taken into account.

Men who have an “unequivocally low morning serum testosterone concentration” along with symptoms of hypogonadism should all be considered candidates for TRT according to Dhindsa.

“Any patient being considered for testosterone replacement therapy should undergo a thorough diagnostic workup,” Dhindsa wrote in a conference press release. “The decision to replace testosterone therapy should be guided by the signs, symptoms, and testosterone concentrations rather than the underlying cause.”

Another press release at the conference noted that the associated risks of TRT such as cardiovascular disease aren’t conclusive. “There is no compelling evidence that TRT either increases or decreases cardiovascular risks” and that “testosterone therapy favorably changes many cardiovascular risk factors by decreasing fat mass, increasing muscle mass, and decreasing insulin resistance,” according to the release.

If left untreated, low testosterone in men can cause a 33% greater chance of death within the next 18 years of a man’s life than men with normal testosterone levels.

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Endocrinologists Criticize FDA’s Advisory Against Testosterone Replacement Therapy

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