MHRA: GLP-1 Drugs Pose No Suicide or Self-Harm Risk

Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) has concluded that there is no conclusive link between GLP-1 receptor agonists and the risk of suicidal thoughts or self-harm. This conclusion aligns with findings from the U.S. and European regulatory bodies. The agency reviewed post-marketing data for five GLP-1 therapies: exenatide, lixisenatide, luraglutide, dulaglutide, and semaglutide, which is produced by Novo Nordisk. In addition to evaluating the risk of suicidal ideation and self-injury, the MHRA also assessed the potential impact of these drugs on depression.

The MHRA's investigation determined that there is no causal association between GLP-1 receptor agonists and suicide, suicidal ideation, self-injury, or depression. Despite this, the agency will continue to closely monitor the possible effects of these medications on severe psychiatric reactions. Currently, there are no recommendations to update the product information sheets for the drugs under review.

This investigation contributes to an ongoing debate regarding the safety of new obesity treatments, particularly surrounding their potential risks for suicide and self-harm. Although existing evidence primarily suggests no significant psychiatric side effects, a note published in JAMA Internal Medicine calls for additional studies, especially involving patients with preexisting mental health conditions.

Concerns about the psychiatric side effects of GLP-1 therapies first emerged in July 2023, when the European Medicines Agency (EMA) noted an increase in such side effects among patients taking semaglutide and liraglutide. The EMA requested further information from GLP-1 drug manufacturers in December 2023 to clarify these findings. By April 2024, the EMA concluded that there was no evidence linking GLP-1 therapies to these psychiatric side effects.

Similarly, the U.S. Food and Drug Administration (FDA) launched its own review of GLP-1 receptor agonists in January 2024. A week later, the FDA announced that it had found no reason to believe that these drugs caused suicidal thoughts or self-harm.

Despite these reassurances from regulatory bodies, some doubts linger. A significant study published in JAMA Network Open utilized data from the World Health Organization’s drug safety database, which is the largest pharmacovigilance archive globally. This study found an increased risk of suicidal ideation associated with semaglutide compared to other drugs. The risk was particularly elevated among individuals concurrently taking antidepressants, where semaglutide increased the likelihood of experiencing suicidal thoughts by more than four times.

In summary, while regulatory agencies in the U.K., U.S., and Europe have found no conclusive evidence linking GLP-1 receptor agonists to suicidal thoughts or self-injury, ongoing monitoring and further research are necessary, especially for patients with existing mental health issues. The current consensus suggests that these obesity treatments do not pose significant psychiatric risks, but vigilance remains crucial as new data becomes available.