Canadian regulators warn consumers about cardiovascular risks of testosterone drugs

Axiron Canadian regulators warn consumers about cardiovascular risks of testosterone drugsCanada’s national health regulators have issued a warning to consumers and health care providers about the serious risks associated with the use of testosterone-replacement drugs, which are being prescribed to increasing numbers of men as a treatment for low natural testosterone levels.

Health Canada said its safety review of testosterone drugs involved evaluating the currently available studies and reports on the cardiovascular risks the drugs presented. In the course of its safety review, the agency found “a growing body of evidence suggesting a possible association between the use of testosterone replacement products and cardiovascular risk.”

As in the U.S., men between the age of 40 and 59 account for most of the testosterone users in Canada, with ages 65 and older being the second most-prescribed age group. The drugs are intended to supplement waning levels of the naturally occurring hormone in aging men who want to restore more youthful energy levels, sex drive, and muscle tone while stabilizing mood and sleep patterns.

Rather than serving as a panacea for aging, however, evidence indicates that testosterone drugs may have disastrous, even deadly effects, on cardiovascular health in some men, including heart attack, stroke, deep vein thrombosis, pulmonary embolism, and irregular heartbeat.

In fact, Health Canada’s warnings come amid a flood of lawsuits and class actions in Canada against the makers of testosterone drugs, many of which allege the manufacturers failed to warn patients and doctors about these potentially deadly effects.

The agency said that it had received 35 reports of cardiovascular problems involving testosterone replacement products as of August 13, 2013. “Some of these reports described the problem as disappearing after the patient stopped using the product or as re-appearing when the patient re-started the product after having temporarily stopped it,” Health Canada said.

In Canada, 12 testosterone-replacement drugs are approved to treat low testosterone in men: Anriol, Androderm, Androgel, Axiron, Delatestryl, Depotestosterone, Testim, and the generic equivalents of these drugs.


Health Canada