Beth Snyder Bulik
Senior Editor
The European Medicines Agency is looking into suicidal and self-harm ideation in three weight loss patients who used Novo Nordisk’s semaglutide or liraglutide medicines.
The case reports were flagged by member agency Icelandic Medicines Agency. The EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is now investigating.
“The case reports included two cases of suicidal thoughts, one following the use of Saxenda and one after Ozempic. One additional case reported thoughts of self-injury with Saxenda,” the EMA said via email to Endpoints News.
The PRAC will now consider whether the review should be extended to include other GLP-1 drugs.
Ozempic is one of Novo’s semaglutide brands. It’s approved to treat type 2 diabetes but is also prescribed off-label for weight loss. Saxenda is one of Novo’s liraglutide brands; it’s approved as a treatment for chronic weight management.
The EMA said that suicidal behavior is not currently listed as a side effect in the approved product information for the drugs, nor is it listed as one on the Ozempic website. However, the website for Wegovy, Novo’s semaglutide brand approved to treat obesity, under important safety information, lists “depression or thoughts of suicide” as one of the possible side effects. The Saxenda website also lists “depression or thoughts of suicide” as a possible side effect.
The FDA requires notification of those specific risks, Novo Nordisk said in a follow-up email, noting the agency “requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation.”
In a statement to Endpoints, Novo Nordisk said that “GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years.”
No clinical trials or post-marketing studies have found a causal link between either drug and suicidal or self-harming thoughts, Novo said. It is “continuously performing” surveillance of real-world data and ongoing studies, which includes monitoring for safety signals.
“Novo Nordisk remains confident in the benefit-risk profile of the products and remains committed to ensuring patient safety,” the company said.
Editor’s note: The story was updated to add a comment from Novo Nordisk about FDA requirements for CNS weight management drugs.
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