Ozempic Flagged by EU After Reports of Suicidal Thoughts

A European drug agency is investigating reports of suicidal thoughts in three people in Iceland taking Ozempic and Saxenda.

The Icelandic Medicines Agency has raised a red flag on a potential adverse event related to Ozempic and another weight loss drug called Saxenda after three people taking the medications experienced suicidal thoughts or thoughts of self-harm while on the medications.

As a result, the European Medicines Agency (EMA) is looking into the event reports and reviewing medicines that contain the active ingredients in the two drugs — semaglutide (Ozempic) and liraglutide (Saxenda). However, the agency did not report any cases of suicide related to the weight loss medications.

This latest review follows a recent concern raised by the EMA about possible links between semaglutide and thyroid cancer.

According to Reuters, in the United States, the weight loss drug Wegovy, which also contains semaglutide, has an alert on the label that people using the medication should be monitored for suicidal thoughts or behavior. However, in the European Union (EU), suicidal thoughts or behaviors are not included in the product information accompanying drugs that contain semaglutide or liraglutide.

In the U.S., the Food and Drug Administration Adverse Event Reporting System (FAERS) has logged around 60 reports of suicidal thoughts in people using semaglutide since 2018 and 70 similar reports related to liraglutide use since 2010.

Still, the FDA has not yet verified the reports, so it's uncertain if these weight loss drugs cause suicidal thoughts or behaviors.

Side effects such as suicidal ideation have also plagued other emerging weight loss drugs. For example, Sanofi's Acomplia — a weight loss drug with mechanisms that differ from GLP-1 receptor agonists like semaglutide — was removed from the European market in 2008 after it was linked to thoughts of suicide or self-harm. However, the FDA never approved the drug in the U.S.

The EMA says it would consider whether to extend the review to other GLP-1 receptor agonists. Although the drug review could result in the removal of medications like Ozempic from the market, labeling changes that include warnings about potential suicidal thoughts are more likely, Reuters reports.