Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products.
The regulator’s Pharmacovigilance Risk Assessment Committee (PRAC) will examine (PDF) Novo’s treatments Ozempic (semaglutide) and Saxenda (liraglutide) to determine if there was a causal relationship between their use and the adverse events. The PRAC also will include another of Novo’s semaglutide drugs, Wegovy, in the study, it said.
The GLP-1 treatments have gained a sudden surge in popularity for their ability to trigger weight loss. The EMA added that it will decide whether to expand its review to all drugs in the popular GLP-1 class. That would include Eli Lilly’s fast-rising Mounjaro (tirzepatide).
As is the case with many other approved weight management medications, suicidal behavior is listed as a major disease interaction with semaglutide and its use should be “avoided in patients with a history of suicidal attempts or active suicide ideation,” according to its label.
In an emailed statement, Novo said that it remains “confident” in the benefit-risk profile of its products and points to the long-standing use of drugs in the class.
“GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for eight years,” the company said. “The safety data collected from large clinical trial programs and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”
Another potential disease interaction with GLP-1 treatments is thyroid cancer. In May, the EMA told Novo and other companies with products in the class—including Lilly, AstraZeneca and Sanofi—that it was monitoring the potential for thyroid cancer signals.
In the recent report from Iceland, there were suicidal thoughts from one user each of Ozempic and Saxenda. Additionally, the self-harm signal was raised by a user of Saxenda.
In 2008, Sanofi’s Acomplia was pulled from the market in Europe—two years after its approval—when some patients suffered depression and suicidal thoughts. The drug, which was a cannabinoid receptor CB1 antagonist, blocked hunger signals to the brain. It was never approved in the U.S. GLP-1 treatments have a different mechanism of action.