Testosterone Heart Problems Result in Warning by Health Canada

Canadian health officials are warning citizens of that country about the potential risk of heart problems associated with side effects of testosterone drugs, such as AndroGel and Testim.

In a safety update issued July 15, Health Canada indicated that a review of a “growing body of evidence” suggests that there is a causal link between use of testosterone replacement therapy (TRT) and an increased risk of men experiencing cardiovascular problems, such as a heart attack, stroke, pulmonary embolism, deep vein thrombosis or irregular heart rates.

In the United States, the FDA announced a similar investigation into the potential risk testosterone heart problems in January 2014, following a series of studies published late last year and early this year that raised concerns about the safety of the medication.

A study published by the Journal of the American Medical Association (JAMA) in November 2013 found that side effects of low testosterone drugs were associated with increased rates of heart attacks, strokes, and death among veterans with pre-existing heart conditions.

That research was followed by a larger study published in the medical journal PLOSOne in January 2014, which involved a review of data on more than 55,000 men who received an initial prescription for testosterone and compared them to men who received a first prescription for an erectile dysfunction drug. The study found that low T treatments may double the risk of heart attack for younger men with pre-existing heart disease, and for men over the age of 65, regardless of their prior heart conditions.

Testosterone Warnings Will Be Added in Canada

Health Canada indicates that it recently completed it’s evaluation of published scientific literature and case reports, and that it is working with drug manufacturers to update testosterone warnings provided on the product labels for medications sold in Canada.

“As of Aug. 31, 2013, Health Canada received 35 reports of cardiovascular problems involving testosterone replacement products,” the testosterone safety review findings state. “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. This may support a possible link between cardiovascular risk and testosterone replacement products.”

The agency determined that 11 of the 35 reports involved heart attacks, pulmonary embolism, or irregular heartbeats that were possibly linked to testosterone use.

Health Canada found that some reports were in patients with a history of conditions such as high blood pressure and diabetes, which may contribute to the risks. The agency advised doctors to screen for such patients when prescribing testosterone and to monitor those patients closely. The agency also advised patients to make their doctors aware of any heart or cardiovascular problems, such as diabetes and high blood pressure.

“The current available evidence suggests the possibility that cardiovascular problems, other than those already identified, may occur with the use of testosterone replacement products,” the review states. “The use of these products in Canada (and internationally) has been increasing and findings from a Canadian study raise additional concerns that these products may not always be used within the approved patient population.”

Testosterone Lawsuits

As men discover that there may be a link between heart attacks and testosterone drugs, serious questions are being raised about the marketing for the drugs, which has resulted in a sharp rise in use of the “Low T” medications over the past year.

In the United States, hundreds of AndroGel lawsuits, Testim lawsuits and other cases involving heart attacks or injuries suffered following use of testosterone drugs have been filed this year.

Most of the complaints involve similar allegations that drug makers aggressively promoted testosterone gel treatments for use among men who had no real medical need, suggesting that men may be suffering from “low T” if they suffered any number of symptoms commonly seen among aging men, including decreased energy, lack of sex drive and weight gain.

As the number of complaints filed in U.S. District Courts nationwide has continued to grow, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases last month, centralizing all testosterone litigation before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.