Wegovy boxes manufactured by Novo Nordisk are seen in a pharmacy in London, UK, March 8, 2024.
Hollie Adams | Reuters
European Union drug regulatory authorities found no evidence that highly regarded weight loss and diabetes drugs such as Wegovy and Ozempic are linked to an increased risk of suicidal thoughts and self-harm, a regulator said on Friday.
The European Medicines Agency conducted a nine-month study of so-called GLP-1 drugs, a blockbuster class of drugs that mimic a hormone produced within the gut to suppress appetite. Demand for these drugs has skyrocketed over the past yr despite their high prices and uneven insurance coverage.
The review examined several drugs with New Nordisk, including Wegovy and Ozempic. It didn’t contain Eli LillyZepbound and Mounjaro, two versions of the identical drug marketed for weight loss and diabetes. But the probe contained the energetic ingredient in an older Eli Lilly diabetes drug called Trulicity.
In an announcement to CNBC, Novo Nordisk confirmed the findings of the EMA investigation and said it will proceed to monitor reports of uncomfortable side effects from its GLP-1, including suicide and suicidal ideation.
The agency’s verdict is the most recent in a series of reassuring reports concerning the suicide risk of GLP-1. The US Food and Drug Administration got here to an analogous conclusion application in January, but said agency officials couldn’t definitively rule out that “there may be a minor risk.”
Clinical trials conducted by Novo Nordisk and Eli Lilly found no association between GLP-1 and suicidal thoughts. Still, researchers and doctors look ahead to any latest unwanted uncomfortable side effects or additional risks as 1000’s of latest patients start taking the drugs.
The EMA first opened an investigation in July after the Icelandic Medicines Agency reported three cases of suicidal thoughts and self-harm in patients taking medicines containing liraglutide and semaglutide, the energetic ingredients in popular treatments.
Semaglutide is the energetic ingredient utilized in the Rybelsus antidiabetic pill from Wegovy, Ozempic and Novo Nordisk. Liraglutide is the energetic ingredient in Novo Nordisk’s older weight loss drug Saxenda. The probe also checked out other energetic ingredients in older weight loss and diabetes drugs, including dulaglutide, exenatide and lixisenatide.
On Friday, the EMA said it had analyzed the outcomes of a big US study and found no direct link between the use of semaglutide and suicidal thoughts. Results from one other study conducted by this agency also found no link between GLP-1 medications and the danger of suicidal thoughts.
Both studies used electronic medical records.
If you might be having suicidal thoughts or are in a difficult situation, please contact Suicide and crisis lifeline dial 988 within the US or Samaritans within the UK on 116 123 for support and assistance from a trained advisor.
Credit : www.cnbc.com