Europe’s drug authority considers heart risks with testosterone replacement therapy

androgel pump 435x435 Europes drug authority considers heart risks with testosterone replacement therapyEuropean drug regulators are weighing whether the benefits of testosterone replacement therapy are worth the risk of life threatening cardiovascular events.

Testosterone therapy, such as AbbVie’s AndroGel, is approved in both the United States and Europe for the treatment of hypogondaism, a condition in which the body does not produce enough testosterone. This can cause symptoms such as low sex drive and muscle loss.

In recent years, makers of testosterone treatments have heavily marketed the drugs directly to consumers, asking men if they suffer from what they deem symptoms of “Low-T” – weight gain, fatigue, and general grumpiness. The campaign was a success, leading to billion-dollar sales of testosterone products in the United States alone.

The drugs appeared to be a godsend, until studies began to surface showing a darker side of the treatment. One study, published in the Journal of the American Medical Association (JAMA) involved more than 9,000 veterans. It found that testosterone treatment increased the risk of heart attack and stroke by 29percent.

Another study found that men younger than 65 with a history of cardiovascular disease were twice as likely to suffer a heart attack within the first three months after starting testosterone treatment.

These studies led the U.S. Food and Drug Administration (FDA) to investigate the drugs, which resulted in a recommendation to clearly state the drug’s indication so that only men with documented hypogonadism are prescribed the drug, and to collect data on cardiovascular risks with testosterone treatments. The FDA also added a new warning for blood clots in the veins.

The same studies prompted the European Medicines Agency (EMA) to launch its investigation into heart attacks, strokes and death with testosterone treatments. So far, the EMA is updating the drug’s label to suggest that men be tested and deemed testosterone insufficient before initiating therapy.

Source: BioPharma