FDA report finds no association between GLP-1s and suicidal thoughts
11 Jan 2024
The FDA has "not found evidence" that GLP-1 receptor agonists such as the ones sold by Novo Nordisk or Eli Lilly cause suicidal thoughts or actions, according to a preliminary report released Thursday.
The investigation was prompted after the agency’s Adverse Event Reporting System reportedly received 265 reports of suicidal thoughts or behaviour in patients taking GLP-1 agonists since 2010.
As part of its preliminary evaluation, the FDA reviewed clinical trials of the drugs, including large outcome studies and observational studies, and did not find an association with their use and suicidal thoughts or actions.
The agency acknowledged, however, that it “cannot definitively rule out that a small risk may exist,” and next plans to conduct a meta-analysis of clinical trials across all GLP-1 agonists, as well as an analysis of postmarketing data in the Sentinel System, its medical product safety surveillance system.
The European Medicines Agency is similarly investigating a link between GLP-1 agonists and the risk of suicidal thoughts and thoughts of self-harm. In December, the agency finished its review of all available evidence from clinical trials, post-marketing surveillance and published literature on reported cases, and while it found that “no conclusion can be drawn on a causal association,” the EMA is requesting further information.
A third-party study also came up empty while looking into an association between suicidal thoughts and Novo Nordisk's semaglutide – sold as Ozempic to treat diabetes, and as Wegovy to combat obesity.
In the January study, published in Nature Medicine, researchers compared anonymized electronic health records from nearly 2 million people who were prescribed semaglutide, or other drugs for weight loss or to lower blood sugar, and did not find an increased risk in suicidal thoughts in those who took Novo Nordisk’s drug.
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