Testosterone Treatments Raise Concern in Canada, Regulators Warn Men about Heart Risks

Published on July 16, 2014 by Sandy Liebhard

Testosterone treatments now blamed for serious heart and blood vessel problems in men have now been flagged for danger in Canada, where regulators have warned the public about these side effects, according to CBC News.

A statement issued July 15th by Health Canada details the possible complications of AndroGel, AndroDerm, Andriol, Axiroin, Delatestryl, Testim and other drugs in an alert that followed an investigation into their safety.

“Health Canada has recently completed a safety review on testosterone replacement products,” the agency said in a statement that day.

As per CBC News, the investigation yielded findings that use of the “Low T” products may increase the risk for heart attacks, strokes, blood clots in the legs or lungs, and a possibily irregular heart rate. The above products will soon contain updated warning labels that reflect these risks.

Women and Children under 18 Should Not Take Testosterone Drugs, Health Canada Warns

According to the Health Canada alert, men with low testosterone levels should be mindful of certain safety information before considering a prescription therapy. First off, men should be sure to undergo laboratory testing to prove they are suffering from abnormally low levels of the hormone before considering AndroGel or another drug. They should also not be used to treat non-specific symptoms, such as low libido, fatigue and other symptoms of aging, according to regulators.

Children under the age of 18 and women should not be taking a prescription testosterone therapy either, as little testing on the medications’ effects has been conducted.

Earlier this year, the U.S. Food and Drug Administration (FDA) issued a similar testosterone drug warning that noted the risk for serious cardiovascular events. In the federal alert on January 31, 2014, the FDA warned that two studies found an increased heart attack risk in older men, as well as younger patients with a history of cardiovascular problems.  The federal warning indicates that no association between “Low T” drugs and these risks had been confirmed, but that its review was ongoing.

In the wake of this FDA alert, testosterone lawsuit filings over AndroGel and other drugs began to be filed in the U.S. Court documents updated on July 15th show at least 156 claims now filed in the U.S. District Court, Northern District of Illinois, where a federal litigation is continuing to move forward.