FDA yet to find link between suicidal risk and GLP-1RA use

The US Food and Drug Administration (FDA) released an update on its evaluation of suicidal risk related to glucagon-like peptide-1 receptor agonists (GLP-1 RAs).

The agency did not find a clear link to suicidal risk through a review of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System agency (FAERS) and a meta-analysis of GLP-1 RA clinical trials. Looking at FAERS data, regulators found that reported incidents were often limited in the information provided and did not offer enough evidence to determine a clear relationship with GLP-1 RA use. Furthermore, the large outcome studies and observational studies showed no association between suicidal thoughts or actions and the use of the drug class. Despite this, the agency said that due to the small number of suicidal ideation cases, it would not yet definitively rule out a potential link with GLP-1RA use. The FDA will share its conclusions upon completion of the assessment.

The regulator urged patients to continue using GLP-1 RAs, per advice from their healthcare providers. The FDA also reminded healthcare professionals to monitor and advise patients using the drugs, checking, and reporting for “new or worsening depression, suicidal thoughts, or any unusual changes in mood or behaviour”, as per the 11 January update.

GLP-1 RAs are a class of drugs that help repair blood glucose control and minimise the risk of heart disease in patients with type 2 diabetes. These therapies are often also used in weight management for obesity. The drugs work by activating GLP-1 receptors in the pancreas, causing an increase in insulin release and reduced glucagon release. In November 2023, the FDA approved Eli Lilly’s Zepbound (tirzepatide) for weight management in obese or overweight patients, making it the 13^th US approval within the drug class.

In July 2023, the European Medicines Agency (EMA) discussed its own ongoing review of the relationship between GLP-1RAs and suicidal thoughts. The review began after the Icelandic Medicines Agency flagged reports of suicidal thoughts and self-injury in patients on liraglutide and semaglutide. Drugs using these active ingredients include Novo Nordisk’s Ozempic and Saxenda. At the time of the announcement, the agency was investigating 150 reports of possible cases of self-injury and suicidal thoughts. In the same month, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced a similar probe reviewing suicidal risk associated with Ozempic and Saxenda.

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