Boxes of Wegovy made by Novo Nordisk are seen at a pharmacy in London, Britain March 8, 2024.
Hollie Adams | Reuters
European Union drug regulators found no evidence that highly popular weight reduction and diabetes drugs corresponding to Wegovy and Ozempic are linked to an increased risk of suicidal thoughts and self-injury, the regulator said Friday.
The European Medicines Agency conducted a nine-month investigation into so-called GLP-1s, a blockbuster class of treatments that mimic a hormone produced within the gut to suppress an individual’s appetite. Those drugs have skyrocketed in demand over the past 12 months despite their hefty price tags and spotty insurance coverage.
The review examined several drugs from Novo Nordisk, including Wegovy and Ozempic. It did not include Eli Lilly‘s Zepbound and Mounjaro, two versions of the identical drug sold for weight reduction and diabetes. However the probe did include the lively ingredient in an older diabetes treatment from Eli Lilly called Trulicity.
In an announcement to CNBC, Novo Nordisk confirmed the findings of the EMA’s investigation and said it is going to proceed to monitor reports of antagonistic reactions to its GLP-1s, including suicide and suicidal ideation.
The agency’s verdict is the most recent in a series of reassuring reports on suicide risk for GLP-1s. The U.S. Food and Drug Administration got here to an analogous conclusion in January but said agency officials couldn’t definitively rule out that a “small risk may exist.”
Clinical trials from Novo Nordisk and Eli Lilly have not demonstrated a link between GLP-1s and suicidal thoughts. Still, researchers and doctors have been looking out for any latest unwanted unwanted effects or added risks as hundreds of latest patients start taking the drugs.
The EMA first launched its investigation in July after the Icelandic Medicines Agency flagged three cases of suicidal thoughts and self-injury in patients taking drugs containing liraglutide and semaglutide, the lively ingredients in the favored treatments.
Semaglutide is the lively ingredient utilized in Wegovy, Ozempic and Novo Nordisk’s diabetes pill Rybelsus. Liraglutide is the lively ingredient in Novo Nordisk’s older weight reduction drug Saxenda. The probe also included other lively ingredients in older weight reduction and diabetes drugs, including dulaglutide, exenatide and lixisenatide.
The EMA on Friday said it analyzed results from a big U.S. study and did not discover a direct association between using semaglutide and suicidal thoughts. Results from one other study conducted by the agency also did not support a link between GLP-1 drugs and the chance of suicidal thoughts.
Each the studies were based on electronic health records.
For those who are having suicidal thoughts or are in distress, contact the Suicide & Crisis Lifeline at 988 within the U.S. or the Samaritans within the U.K. at 116 123 for support and assistance from a trained counselor.