- European Union regulators are examining whether people taking Novo Nordisk’s diabetes and weight-loss drug Ozempic are at higher risk of having thoughts of suicide or self-harm. The European Medicines Agency’s drug safety panel is basing its probe on three cases reported by Iceland’s drug regulator, the EMA said.
- The probe covers several Novo products containing the active ingredients liraglutide and semaglutide, which includes the blood sugar-lowering shot Victoza as well as Rybelsus, the first oral drug of this type of treatment.
- In a statement, the EMA said it is considering extending the review to other drugs from the same class, such as Eli Lilly’s Trulicity and Mounjaro. That class, called GLP-1 agonists, is Novo Nordisk’s biggest seller, accounting for 57% of its total sales in 2022.
The Icelandic drug agency reported two cases of suicide “ideation,” one from a person taking Saxenda, a daily weight-loss shot containing liraglutide, and another on Ozempic, the weekly diabetes shot containing semaglutide that is also widely used for weight loss. A third person had thoughts of self-injury while taking Saxenda, the EMA said.
The three cases constituted a “signal” that necessitated an evaluation by EMA’s Pharmacovigilance Risk Assessment Committee. That panel discussed the cases at a meeting last week.
GLP-1s, which help people with diabetes by stimulating insulin secretion and curbing appetite, have grown into one of the biggest drug classes because of their potent effects on blood sugar and body weight. Novo’s GLP-1s had sales of about 100 billion Danish kroner, or $14.2 billion, in 2022, while Lilly’s GLP-1s had sales of $7.9 billion.
Novo has largely had the weight-loss segment to itself with Saxenda and Wegovy, the version of semaglutide that is approved to treat obesity. (Ozempic is also used off-label.) But Lilly is advancing quickly with Mounjaro in weight loss, for which it could gain approval by the end of 2023. Mounjaro acts on GLP-1 and another target called GIP.
Because the drugs are used by so many people, regulators are alert to any sign of potential risk. In the 1990s, a popular weight-loss combination called fen-phen caused damage to users’ heart valves, leading to billions of dollars in legal settlements.
GLP-1s already carry a black box warning about the potential for a type of thyroid cancer because of cases seen in animal testing.