Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News | Scoop.it

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.