OTTAWA – Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems. Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics. Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified. Health Canada would like to remind the public of the following important information from the Canadian Product Monographs regarding the use of testosterone products: They should not be used in men for non-specific symptoms if laboratory tests have not been done to confirm a low testosterone level and other possible causes for the symptoms have not been excluded. They should not be used in children under the age of 18 as the safety and effectiveness has not been established in these patients. They should not be used by women.
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