FDA ‘evaluating regulatory action’ over link between GLP-1 receptor agonists and suicidal thoughts

The US Food and Drug Administration said it had received reports of suicidal ideation in patients taking GLP-1 receptor agonists through its adverse events reporting system.
Man about to injection glp-1 ra

The US Food and Drug Administration (FDA) is “evaluating the need for regulatory action” on glucagon-like peptide-1 receptor agonists (GLP-1 RAs), following reports of suicidal ideation linked to the drugs in the United States.

In an update posted on its website on 2 January 2024, the US FDA confirmed that it was carrying out the review of 13 products because of risks identified through its adverse events reporting system.

GLP-1 RAs are used for managing blood glucose levels in people with type 2 diabetes mellitus but have gained popularity for their use in weight loss.

In the UK, in March 2023, the National Institute for Health and Care Excellence recommended use of semaglutide injections for weight management on the NHS. The Medicines and Healthcare products Regulatory Agency (MHRA) then approved tirzepatide for the same purpose in November 2023.

In December 2023, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee announced an update on its review of GLP-1 RAs and suicidal thoughts and thoughts of self-harm, which began in July 2023.

It said: “While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified.

“The committee has agreed further lists of questions to be addressed by the respective marketing authorisation holders for these medicines.”

In July 2023, the MHRA launched its own review into the risk of suicidal thoughts and thoughts of self-harm associated with GLP-1 RAs.

The UK review included exenatide, liraglutide, lixisenatide, dulaglutide and semaglutide.

On 8 January 2024, the UK regulator told The Pharmaceutical Journal: “The MHRA review is still in progress, and we cannot provide specific timelines or results at this time.”

According to MHRA Yellow Card reporting scheme, there have been 28 reports of suicidal and self-injurious behaviour among patients taking semaglutide and 23 reports for patients taking liraglutide.

There are currently no reports of the psychiatric adverse reaction to tirzepatide.

Last updated
The Pharmaceutical Journal, PJ, January 2024, Vol 312, No 7981;312(7981)::DOI:10.1211/PJ.2024.1.208135

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