Testosterone replacements can increase the risk of serious heart and blood vessel problems, Health Canada says.
The regulator said 12 testosterone replacement products are available, such as Androderm, Andriol, Delatestryl, Androgel, Axiroin, Depo-Testosterone, Testim, and their equivalent generics.
Men use the products because their bodies can’t make enough testosterone.
"Health Canada has recently completed a safety review on testosterone replacement products," the department said Tuesday.
"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 said it is working with manufacturers to update the product labels to describe the risk.
It also reminded the public about safety information on 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.
Patients should be assessed for cardiovascular risk factors before starting testosterone therapy.