NETHERLANDS — In response to reports of patients experiencing thoughts of suicide or self-injury, the European Medicines Agency (EMA) has launched an investigation into weight management drugs manufactured by Novo Nordisk.
The probe will initially concentrate on the risks associated with weight-loss medications containing semaglutide or liraglutide, which are commonly used to manage diabetes.
However, the scope of the review may potentially extend to include other GLP-1 receptor agonists, as stated by the EMA.
Novo Nordisk’s Ozempic, Rybelsus, and Wegovy contain semaglutide, while liraglutide is present in Saxenda, Victoza, and Xultophy.
An EMA official explained that the review was initiated following three case reports, brought forward by the Icelandic Medicines Agency.
“The case reports included two instances of suicidal thoughts—one associated with the use of Saxenda and another with Ozempic. Additionally, one case reported thoughts of self-injury related to Saxenda,” the official stated.
Currently, the EU product information for these medications does not list suicidal behavior as a side effect.
Therefore, the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA will assess whether the review should encompass other medicines within the same class.
Maintaining a focus on safety
Novo Nordisk released a statement asserting its collaboration with the EMA while maintaining confidence in the safety record of its drugs.
The statement emphasized the use of GLP-1 receptor agonists for over 15 years in treating type 2 diabetes and eight years for managing obesity, including their own products, semaglutide and liraglutide, which have been on the market for more than a decade.
The company representative highlighted that extensive safety data collected from large clinical trials and post-marketing surveillance have not indicated a causal connection between semaglutide or liraglutide and thoughts of suicide or self-harm.
Novo Nordisk also emphasized its ongoing monitoring of data from clinical trials and real-world use of their products to ensure patient safety.
The company assured that it works closely with regulatory authorities and remains confident in the favorable risk-benefit profile of their products.
In the United States, the labels for Wegovy and Saxenda, the two Novo Nordisk drugs specifically approved for weight management, do include warnings about suicidal behavior and ideation.
Additionally, Ozempic, which also contains semaglutide and is primarily used to treat type 2 diabetes, has faced shortages due to off-label prescribing for weight loss.
Meanwhile, Eli Lilly’s Mounjaro (tirzepatide), another GLP-1 receptor agonist targeting type 2 diabetes, has encountered supply issues stemming from off-label use in obesity.
The company aims to expand Mounjaro’s label to include weight loss indications as well.
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