Health Canada Safety Review: No GLP-1 Suicide Link in T2D Patients

What the regulator reviewed

The review covered dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide-containing products, and was triggered by case reports of suicidal thoughts and self-harm submitted to the European Medicines Agency [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090]. Health Canada examined manufacturer-submitted information, the Canada Vigilance database, the World Health Organization's adverse drug reaction database and the scientific literature [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090].

Health Canada reviewed 15 cases (3 Canadian and 12 international) of suicide, self-harm and suicidal/self-harm ideation in patients using GLP-1 RAs, including 2 from the published literature [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090]. Of those 15 cases, 12 were found to be possibly linked to the use of GLP-1 RAs and 3 could not be assessed due to missing clinical information [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090].

Confounding factors limited certainty

The review noted that a definitive link could not be confirmed due to insufficient information about possible confounders, including pre-existing mental health problems, family history, life stressors, social and environmental factors, and use of other medications with labelling related to suicidality [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090].

Health Canada also reviewed clinical trial data from manufacturers and real-world data from published and unpublished sources. Overall, that evidence did not support a link in patients with type 2 diabetes, but the evidence was not as clear in the subgroup of patients with obesity, with or without type 2 diabetes [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090].

Products and prescribing footprint in Canada

According to the review, GLP-1 receptor agonists authorized in Canada include Ozempic/Rybelsus (semaglutide), Victoza (liraglutide), Trulicity (dulaglutide), Xultophy (insulin degludec and liraglutide) and Soliqua (insulin glargine and lixisenatide) for adults with type 2 diabetes, and Wegovy (semaglutide) and Saxenda (liraglutide) for chronic weight management in adults and adolescents who are obese or overweight [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090].

GLP-1 RAs have been marketed in Canada since 2010, and approximately 7.1 million prescriptions for GLP-1 RAs were dispensed by Canadian retail pharmacies in 2023 [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090]. All GLP-1 RA products are available as subcutaneous injections, and semaglutide is also available as an oral tablet [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090].

Health Canada's actions

The regulator published a Health Product InfoWatch communication in December 2024 to share information about the review with healthcare professionals [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090]. Health Canada said it will continue to monitor the safety of GLP-1 RAs and encouraged consumers and healthcare professionals to report any side effects to the Canada Vigilance Program [Source: dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1737728420090].

Context: expanding GLP-1 use in Canada

The safety review lands as the GLP-1 class continues to grow in Canada. On April 28, 2026, Health Canada authorized the first generic semaglutide injection, a Dr. Reddy's Laboratories product referenced to Ozempic, making Canada the first G7 country to approve a generic version of semaglutide [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. Health Canada said it is currently reviewing eight other submissions for generic semaglutide and expects to make additional regulatory decisions in the coming weeks and months [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

Alberta Blue Cross, in its 2026 drug pipeline report, said GLP-1 therapies remain a major cost driver and that future expanded uses could include metabolic dysfunction-associated steatohepatitis (MASH) and obstructive sleep apnea (OSA) [Source: ab.bluecross.ca/plans/group/drug-pipeline-2026.php]. The insurer added that while a semaglutide generic is expected in mid-2026, overall GLP-1 therapy plan spend is unlikely to decline in future years due to growing use and continued expansion of GLP-1 therapies [Source: ab.bluecross.ca/plans/group/drug-pipeline-2026.php].

HR Reporter noted that Health Canada said many generic medicines in Canada are 45% to 90% cheaper than their brand-name counterparts [Source: hrreporter.com/focus-areas/compensation-and-benefits/canada-first-in-g7-to-approve-generic-ozempic/394374]. Patients comparing Canadian pharmacy prices can use the generic semaglutide tracker, the insurance coverage checker, or the FAQ on GLP1Prices.ca, which also tracks Mounjaro and Zepbound.