EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

On April 12, 2024, the European Medicines Agency announced that its Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there is no link between glucagon-like peptide-1 (GLP-1) receptor agonists and suicidal or self-harming thoughts or actions. GLP-1 receptor agonists (e.g., dulaglutide, exenatide, liraglutide, lixisenatide, and semaglutide) are used to treat type 2 diabetes; some of these medications are also authorized for weight management.

In July 2023, PRAC began a review of these medicines after reports of users of liraglutide and semaglutide having thoughts of suicide and self-harm (1). PRAC requested additional data from marketing authorization holders of these types of drugs in November 2023. Results from a study published in 2024 were also analyzed by PRAC (2). The study examined the risk of suicide and self-harm in patients with type 2 diabetes. The study results did not show there to be a link between GLP-1 receptor agonists and a risk of suicide/self-harm thoughts or actions.

“After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies the PRAC considers that no update to the product information is warranted. The marketing authorization holders for these medicines will continue to monitor these events closely, including any new publications, as part of their pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs),” EMA stated in a press release.

In January 2024, FDA also found no causal link between the drugs and thoughts of suicide after a preliminary evaluation. “Because the information provided was often limited and because these events can be influenced by other potential factors, we determined that the information in these reports did not demonstrate a clear relationship with the use of GLP-1 RAs. Similarly, our reviews of the clinical trials, including large outcome studies and observational studies, did not find an association between use of GLP-1 RAs and the occurrence of suicidal thoughts or actions. However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, we cannot definitively rule out that a small risk may exist; therefore, FDA is continuing to look into this issue,” FDA stated (3).

EMA’s PRAC also provided safety information to healthcare professionals regarding new Rybelsus tablets (oral semaglutide) on April 12. PRAC was asked to consult on a proposed direct healthcare professional communication (DHPC) as part of an ongoing application for new strengths of Rybelsus tablets. PRAC agreed to the content in the DHPC, and it will be forwarded to the Committee for Medicinal products for Human Use for adoption. Once finalized, the DHPC will be provided to healthcare professionals by marketing authorization holders. Rybelsus is used control blood glucose levels in adults with type 2 diabetes.

References

1. EMA. EMA Statement on Ongoing Review of GLP-1 Receptor Agonists. Press Release. July 13, 2023.
2. Wang, W.; Volkow, N. D.; Berger, N. A.; et al. Association of Semaglutide with Risk of Suicidal Ideation in a Real-World Cohort. Nat Med 2024, 30, 168–176.
3. FDA. Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions in Patients Taking a Certain Type of Medicines Approved for Type 2 Diabetes and Obesity. FDA.gov. Jan. 30, 2024 (accessed Apr. 12, 2024).

Source: EMA