Testosterone replacement products are used in men whose bodies don't make enough of the hormone, causing such effects as flagging libido, low energy, loss of muscle, mood swings and disturbed sleep.
A recent Health Canada safety review found a growing body of evidence suggesting that the use of replacement testosterone may pose an increased risk of heart attack, stroke, blood clots in the lungs or legs, and heart rhythm irregularities.
The federal department says testosterone replacement products should not be used in men for non-specific symptoms if lab tests have not confirmed a low testosterone level, nor should they be used in children under 18 nor in women.
Men should advise their doctor of any history of cardiovascular disease or symptoms that might indicate such disease before using testosterone replacement therapy.
The agency also says health providers should assess patients for cardiovascular disease risks before prescribing testosterone and closely monitor men who begin hormone replacement.
In Canada, 12 testosterone replacement products are approved for sale, including such brand-name products as Androderm, Delatestryl, Androgel and Testim, as well as various generic equivalents.