Wegovy, Ozempic Suicide Ideation Risk Prompts EMA Review

The European Medicines Agency (EMA) is conducting a safety review of GLP-1 receptor agonists such as Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) following 150 reports from the Icelandic Medicines Agency of suicidal thoughts and self-injury in people using one of the drugs for weight loss or type 2 diabetes.

The review of Ozempic, Saxenda and Wegovy started on July 3, but has now been extended to include other GLP-1 agonists such as dulaglutide, exenatide and lixisenatide.  

The reports are being analyzed by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) and it is not clear yet whether the reported cases are linked to the drugs or to the patients’ underlying conditions or other factors, the EMA stated.

The review is being done as a “signal procedure” — information on a new adverse event that is “potentially caused by a medicine or a new aspect of a known adverse event that warrants further investigation,” the EMA explained. PRAC expects to conclude the review in November 2023.

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