The results of a nine-month investigation by health authorities in the European Union should be reassuring to anyone taking Ozempic and other similar drugs to treat type 2 diabetes and/or obesity. EU officials said on Friday they had found no evidence of a causal link between GLP-1 drugs and an increased risk of suicide or suicidal ideation.
Last summer, health authorities in Iceland, the UK and the EU said they had received case reports linking GLP-1 drug use to suicidal thoughts. The drugs mentioned in these reports were liraglutide and semaglutide, the latter being the first of a new, significantly 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 the treatment of 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 drugs. The results of the review were set out in detail at the final PRAC meeting this week – and they are extremely reassuring.
“The PRAC has concluded that the available evidence does not support a causal relationship between the glucagon-like peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide – and suicidal and self-harming thoughts and actions “, the EMA announced in a statement Approved Friday.
To reach these conclusions, the review authors analyzed case reports, data collected by drug manufacturers, and the results of a Recent study electronic health records (one in which no link was found between suicide and GLP-1 use). The EMA also conducted a separate health records analysis focusing specifically on people taking GLP-1 for type 2 diabetes and also found no link.
The EMA investigation is the second recent investigation by health authorities to find a link between GLP-1 drugs and suicide. In January, the FDA reported that his preliminary assessment showed no evidence of an increased risk of suicide. And some recent research even suggests that GLP-1 drugs may have mental health benefits, such as in one paper published In February of this year, GLP-1 use was found to be associated with lower rates of anxiety and depression.
Of course, GLP-1 also has disadvantages. For example, they often cause nausea and other gastrointestinal problems. They were probably associated with others too rare but serious complications like gastroparesis. And as with any medication, not everyone who could benefit from taking it will respond to or tolerate the side effects.
The FDA announced in January that it was still finalizing the results of its investigation. And the EMA said on Friday that makers of GLP-1 drugs 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.