The results of a nine-month investigation by European Union health regulators should be reassuring for anyone taking Ozempic and other similar drugs to treat type 2 diabetes and/or obesity. EU officials said Friday they had not found evidence of a causal 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 they had received case reports linking the use of GLP-1 drugs to suicidal ideation. The drugs mentioned in these reports were liraglutide and semaglutide, the latter being the first in a new generation much more efficient 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 (Europe’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 drugs and other GLP-1 drugs. The findings of the review were detailed at the latest PRAC meeting this week and are very reassuring.
“The PRAC concluded that the available evidence does not support a causal association between glucagon-like peptide-1 (GLP-1) receptor agonists – dulaglutide, exenatide, liraglutide, lixisenatide and semaglutide – and suicidal thoughts and actions and of self-harm. “, announced the EMA in a press release. released Friday.
To arrive at these conclusions, the review authors analyzed case reports, data collected from drug manufacturers and the results of a recent study electronic health records (one that failed to find a link between suicide and GLP-1 use). The EMA further conducted a separate analysis of health records looking specifically at people taking GLP-1 for their type 2 diabetes and also found no link.
The EMA investigation is the second recent investigation by health regulators to rule out any links between GLP-1 drugs and suicide. In January, the FDA reported that its preliminary assessment found no evidence of an increased risk of suicide. And some recent research has even suggested that GLP-1 drugs may have mental health benefits, like one article published This past February, a study found that GLP-1 use was linked to lower rates of anxiety and depression.
Of course, GLP-1s have their drawbacks. They usually cause nausea and other gastrointestinal symptoms, for example. They have also been linked to other likely people rare but serious complications like gastroparesis. And as with any medication, not everyone who might benefit from it will respond or be able to tolerate the side effects.
The FDA said in January that it was still finalizing the results of its investigation. And the EMA said Friday that GLP-1 drugmakers will continue to monitor their data for these and other potential complications and report any new findings as part of standard safety practices after approval.
