Health Canada Flags Testosterone Replacement Therapy for Serious Side Effects

Health Canada has issued a safety warning in its July safety review that testosterone, or low-T, treatments are responsible for increased health risks. The Canadian government organization reviewed various case reports and scientific studies that indicated life-threatening issues such as blood clots, heart attacks, congestive heart failure, atrial fibrillation and stroke were linked to use of testosterone therapy products. After reviewing the risks found in the studies, Health Canada has issued a warning for serious testosterone therapy side effects.

This is not the first warning related to the risks of testosterone replacement therapy. The U.S. Food and Drug Administration also released warnings for Low-T use earlier this year. Over the last 10 years, prescriptions filled for testosterone treatment have dramatically increased despite mounting evidence of health concerns, like this January 2014 study, which observed a two to three-fold increased risk of heart attack during testosterone treatments.

As a result of the safety warning, Health Canada is requiring testosterone therapy manufacturers to update their warning labels to include additional safety information regarding cardiovascular risks, which include heart attack, stroke, blood clots in the lungs or legs, and irregular heart rate.

Testosterone therapy is approved for use in adult males who experience medical conditions as a result of their inability to produce testosterone. In addition to generic products, there are seven name-brand testosterone replacement products listed in the Health Canada warning:

  • Androderm
  • Andriol
  • Delatestryl
  • AndroGel
  • Axirion
  • Depo-Testosterone
  • Testim

Testosterone Replacement Therapy Precautions

Low-T treatments are sometimes prescribed to men who do not need it or pose a higher risk for cardiovascular issues. To help avoid this, Health Canada has released directions and precautions for use of testosterone products:

  • Only use if a low testosterone level has been confirmed from laboratory testing
  • Only use if cardiovascular risk factors have been assessed by a doctor before starting Low-T therapy
  • Do not use for men with non-specific symptoms
  • Do not use for women and persons under 18
  • Patients should inform doctors of any cardiovascular health issues before or during treatment
  • Doctors should monitor cardiovascular health throughout treatment


Simmons Support Team
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