Pharmaceutical

European group issues statement regarding use of testosterone replacement therapy

Low T1 European group issues statement regarding use of testosterone replacement therapyRecent controversy in the United States regarding the overprescribing of testosterone replacement therapy to aging men, and cardiovascular side effects associated with the hormones, have prompted the European Menopause and Andropause Society (EMAS) to issue a statement saying testosterone treatments should not be offered to all aging men, and that candidates be evaluated for co-morbidities that could affect natural testosterone levels and increase side effects from treatment.

Testosterone treatments, which includes the brand names AndroGel and Axiron, are intended for men who suffer from hypogonadism, a condition in which men do not produce enough testosterone due to disease or injury. Symptoms of hypogonadism include a decrease in libido, muscle loss, weight gain and erectile dysfunction.

Age-related hypogonadism, or a drop in testosterone as a man ages, is natural and should not be treated with testosterone supplements. However, manufacturers of testosterone therapies have in recent years promoted the use of testosterone for men with age-related hypogonadism, a condition they dubbed “Low T.” This has resulted in skyrocketing prescriptions for testosterone replacement therapies in the United States.

The Food and Drug Administration (FDA) recently cracked down on testosterone manufacturers for their direct-to-consumer ads promoting testosterone use, ordering drug makers to use stricter language for the indication of the medication to curb overprescribing of the medication. The agency also ordered that warnings be added to the safety labels regarding blood clot risk and risk of heart attacks, strokes and death.

A recent study found that men who used testosterone were 30 percent more likely to have a heart attack , stroke or die after three years of use. Another study showed that men had a significant increase in risk of heart attack and stroke in the first 90 days of testosterone use.

Manufacturers of testosterone products are facing hundreds of lawsuits from men who claim they were not adequately warned of the cardiovascular risks of testosterone replacement therapy.

Source: PharmPro