The European Medicines Agency refutes associations between GLP-1 RAs and suicidal ideation

The agency in charge of EU drug-related regulations argues that there's not enough evidence to label Ozempic-like drugs with a warning over self-injurious thoughts and actions.

The following is a quick update regarding investigations into GLP-1 RAs such as Ozempic Wegovy and some reports associating these medications with increased risk of suicidal ideation. In short, a review body in charge of the EU’s regulation of medications has recently argued that there isn’t sufficient evidence at this moment to update GLP-1 RA labels to reflect a possible increased risk of suicidal ideation.

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With more people using GLP-1 RAs such as Ozempic there have been several concerning adverse events being reported. I have covered several of them previously so please wander around my Substack for some information regarding those adverse events.

A more recent and concerning question came about a few months ago, in which many regulatory agencies across the globe including the FDA as well as the EU’s European Medicines Agency (EMA) began investigating if the use of these now weight-loss drugs may be tied with suicidal ideation in some way:

However, last week the EMA has come back with their findings in which they argue that there doesn’t appear to be significant evidence tying suicidal thoughts to use of these medications, as suggested in their April 12 pharmacovigilance report:

With the first sentence of the article stating the following:

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.

Bear in mind that this report doesn’t suggest that there may be no link between GLP-1 RAs and suicidal ideation, but that there isn’t enough evidence to warrant an update to these products’ warning labels to reflect these possible signals.

The decision appears to be based on available information, but it also appears that two studies in particular helped to sway the review committee:

Additionally, the committee analysed the results of a recent study¹, based on a large database of electronic health records, which investigated the incidence of suicidal thoughts in patients with overweight and type 2 diabetes mellitus treated with semaglutide or other non-GLP-1 receptor agonist medicines for diabetes or overweight. The study found no causal association between the use of semaglutide and suicidal thoughts.

Another study was conducted by EMA², based on electronic health records, which examined the risk of suicide-related and self-injury-related events in people with type 2 diabetes mellitus. The results did not support a causal association between the use of GLP-1 receptor agonists and this risk.

I haven’t been able to look at the data presented in its entirety so I can’t make any comment regarding the robustness of these studies.

That being said, note that the latter study cited refers to a study which looked at people on GLP-1 RAs for their Type II diabetes. These patients also likely had obesity, but when comparing studies to real-world populations it's important that referenced studies properly capture the intended group.

That is, because the second study looked at people with Type II diabetes in particular it doesn’t tell us much about these findings when GLP-1 RAs are used in a broader context as they are being used right now, and is even stated as a possible limitation of this study:

It is worth noting that the limited sample size of new users of GLP-1 receptor agonist patients with a history of obesity but not history of T2DM precludes the conduct of a study with a focus on this population.

Also, note that these studies generally don’t compare GLP-1 RA users to those not on medications but rather people who may be on other anti-obesity/anti-diabetes medications as well and therefore won’t take into account whether these medications as a whole may be associated with increased risk of suicidal ideation.

All this to say that the data referenced may not be a good representation of users of GLP-1 RAs. It also doesn’t suggest that these drugs may still be safe. Precaution should be taken as more users of GLP-1 RAs may come with other signals of possible adverse events.

It will be interesting to see if these findings are reflected in other regulatory bodies, and to see what evidence is used to make such arguments.

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Other GLP-1 RA Adverse Events (for those interested)

Users of Ozempic-like drugs report stomach paralysis as a side effect

FDA updates Ozempic label to include intestinal paralysis as an adverse reaction

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