Health Canada Warns of Cardiovascular Risks Associated with Testosterone Therapy Drugs
On July 15, 2014, Health Canada warned patients and healthcare professionals of serious and possibly life-threatening cardiovascular risks associated with testosterone replacement therapies.
Health Canada recently completed a safety review of low-testosterone products, which revealed that Low-T product use is linked to heart and blood vessel problems, such as heart attack, stroke, pulmonary embolisms (blood clot in the lung), deep vein thrombosis (blood clot in the leg or pelvis), and an increased or irregular heart rate. The Canadian agency asserts that a vast body of evidence comprising of published scientific literature and case reports received by Health Canada and foreign regulators, including the U.S. Food and Drug Administration (FDA), support the findings linking testosterone replacements therapies to cardiovascular risks. Health Canada is working with manufacturers to update the Canadian product labels to reflect these risks.
The Canadian agency is also working with foreign regulators, such as the FDA and the European Medicines Agency, over this growing safety concern. The FDA recently issued its own safety notification to health care professionals and organizations that it is requiring Low-T product manufacturers to include a warning about the risk of venous blood clots associated with the testosterone replacement therapies.
There are 12 Low-Testosterone products currently on the market in Canada: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.
If you or a loved one has suffered injuries after using testosterone products, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.
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