EMA review of suicide risk for Ozempic, Saxenda extended to other GLP-1 receptor agonists | Biospace

Pictured: The 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 the treatment of type 2 diabetes.

The review was initiated by the Icelandic Medicines Agency following reports of suicidal thoughts and self-harm in people using liraglutide and semaglutide medicines. Authorities have recovered and are analyzing around 150 reports of possible cases of self-harm and suicidal thoughts, according to the EMA’s announcement on Tuesday.

“It is not yet clear whether the reported cases are related to the drugs themselves or to the patients’ underlying conditions or other factors,” the agency said.

The review is expected to conclude in November 2023.

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

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Original story, July 11:

The European Medicines Agency has identified the risks of self-harm and suicidal thoughts that could potentially be linked to Novo Nordisks medicines containing the active substances semaglutide and liraglutide.

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

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

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

This class, called GLP-1 receptor agonists, includes Novos Wegovy, Victoza and Rybelsus, as well as Eli Lillys Mounjaro.

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

In the US, however, Saxenda carries a warning for suicidal ideation and behavior, as well as advising providers of the need to monitor patients for depression. According to the drug label, nine out of 3,384 patients treated with Saxenda experienced suicidal ideation. This corresponded to a rate of 0.3%, compared to only 0.1% against placebo. A patient on Saxenda attempted suicide.

In a pediatric study, a patient receiving Saxenda died by suicide, although there was insufficient 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 stop treatment if these side effects develop. Ozempic and Wegovy contain the same active ingredient semaglutide.

Novos semaglutide and liraglutide, along with Lillys tirzepatide, all belong to the class of drugs called GLP-1 receptor agonists. These treatments work by mimicking the hormone GLP-1 and activating its corresponding receptor, thereby causing the pancreas to release an adequate amount of insulin in response to blood glucose levels.

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

Tristan Manalac is a freelance science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.