The results of a nine-month investigation by health regulators in the European Union should be comforting for anyone taking Ozempic and other similar drugs to treat type 2 diabetes and/or obesity. EU officials said Friday that they failed to find evidence of a causative link between GLP-1 drugs and an increased risk of suicide or suicidal ideation.
Last summer, health regulators in Iceland, the UK, and the EU announced that they had received case reports tying the use of GLP-1 drugs to suicide ideation. The drugs mentioned in these reports were liraglutide and semaglutide, the latter of which is the first of a new, much more effective generation of anti-obesity medications (Ozempic is the brand name of semaglutide approved by the FDA for type 2 diabetes, while Wegovy is approved for obesity).
In response to these reports, the European Medicines Agency (the EU’s version of the Food and Drug Administration) announced that it would appoint members of its Pharmacovigilance Risk Assessment Committee to conduct a review of these and other GLP-1 medications. The findings of the review were detailed during the latest PRAC meeting held this week—and they’re plenty reassuring.
“The PRAC has concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 receptor agonists (GLP-1)—dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide—and suicidal and self-injurious thoughts and actions,” the EMA announced in a statement released Friday.
To come up to these conclusions, the review authors analyzed case reports, data collected from the drug makers, and the results of a recent study of electronic health records (one that failed to find a link between suicide and GLP-1 use). The EMA additionally conducted a separate analysis of health records that focused specifically on people taking GLP-1s for their type 2 diabetes and similarly found no link at all.
The EMA’s probe is the second recent investigation by health regulators to clear GLP-1 drugs of a link to suicide. In January, the FDA reported that its preliminary assessment had found no evidence of an increased suicide risk. And some recent research has even suggested that GLP-1 drugs could have mental health benefits, such as a paper published this February that found GLP-1 use was linked to lower rates of anxiety and depression.
Of course, GLP-1s do have their drawbacks. They commonly cause nausea and other gastrointestinal symptoms, for instance. They’ve also been tied to other likely rare but serious complications such as gastroparesis. And like with every drug, not everyone who could benefit from taking them will respond or be able to tolerate the side effects.
The FDA said in January that it is still finalizing the results of its investigation. And the EMA said Friday that GLP-1 drug makers will continue to monitor their data for these and other potential complications and report any new findings as part of standard post-approval safety practices.