EMA Review of Suicide Risk for Ozempic, Saxenda Extended to Other GLP-1 Receptor Agonists

Pictured: EMA building at its old headquarters in London/iStock, Lubo Ivanko

Pictured: EMA building at its old headquarters in London/iStock, Lubo Ivanko

The European Medicines Agency has extended its review of a potential suicide risk associated with Novo Nordisk's Ozempic and Saxenda to other GLP-1 receptor agonists used for weight loss and treating Type 2 diabetes.

The review was triggered by the Icelandic Medicines Agency following reports of suicidal thoughts and self-injury in people using liraglutide and semaglutide medicines. Authorities have retrieved and are analyzing about 150 reports of possible cases of self-injury and suicidal thoughts, according to EMA's Tuesday announcement.

"It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors," the agency said. 

The review is expected to conclude in November 2023.

Liraglutide and semaglutide medicines are widely used, with an exposure of more than 20 million patient-years to date.

Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn.


Original story, July 11:

The European Medicines Agency has identified risks of self-harm and suicidal ideation that could potentially be linked to Novo Nordisk’s medications containing the active ingredients semaglutide and liraglutide.

The potential risks were first identified by the Icelandic Medicines Agency, according to a CNN report, citing the EMA. Iceland’s regulator documented one case of suicidal ideation in a patient who had taken the diabetes drug Ozempic (semaglutide) and another after using the weight-loss medicine Saxenda (liraglutide).

A third incident involving thoughts of self-harm was also detected in a patient who was receiving Saxenda.

The Pharmacovigilance Risk Assessment Committee (PRAC), the EMA’s main group responsible for assessing and monitoring the safety of drug products, has put both treatments under review. The committee is also evaluating whether it will need to extend the review to other products in this drug class, according to CNN.

This class, called GLP-1 receptor agonists, include Novo’s Wegovy, Victoza, and Rybelsus, as well as Eli Lilly’s Mounjaro.

Ozempic was approved for use in the European Union in February 2018, while Saxenda won the regulatory nod in March 2015. The EU package inserts for both products do not bear safety warnings for suicidal or self-harm ideation.

In the U.S., however, Saxenda carries a warning for suicidal behavior and ideation, as well as alerting  providers to the need to monitor patients for depression. According to the drug’s label, nine in 3,384 patients given Saxenda experienced suicidal ideation. This corresponded to a rate of 0.3%, as opposed to only 0.1% in placebo comparators. One patient on Saxenda attempted suicide.

In a pediatric trial, one patient given Saxenda died by suicide, though there was not enough data conclusively and causally linking this fatality to the treatment.

Ozempic has no such precautions, but Wegovy does, along with a note to avoid treatment in patients with a history of suicidal thoughts and behaviors—and to discontinue treatment in case these side effects develop. Ozempic and Wegovy carry the same active ingredient semaglutide.

Novo’s semaglutide and liraglutide, together with Lilly’s tirzepatide, all belong to the drug class called GLP-1 receptor agonists. These treatments work by mimicking the GLP-1 hormone and activating its corresponding receptor, thereby inducing the pancreas to release an appropriate amount of insulin in response to blood glucose levels.

These medicines typically induce gastrointestinal toxicities, such as nausea and vomiting, but can also trigger injection site reactions and headaches.

Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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