BRUSSELS (Reuters): The European Medicines Agency is looking into Novo Nordisk’s (NOVOb.CO) weight-loss drugs after several reports of suicidal risks were referred to the watchdog, the regulator said on Monday.
A safety committee is looking at adverse events flagged by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to Novo Nordisk’s Ozempic and Saxenda, the EMA said.
One additional case on Saxenda reported thoughts of self-injury, the agency said.
The EMA is investigating these possible side effects in relation to medicines that contain the active ingredients semaglutide or liraglutide for weight loss.
Suicidal behavior is not currently listed as a side effect in the EU product information of these treatments.
The EMA will consider whether the review should be extended to also include other medicines of the same class known as GLP-1 receptor agonists.
Novo’s obesity drugs Wegovy and Ozempic, approved for diabetes patients, contain the active ingredient semaglutide, while Saxenda contains liraglutide.
Novo said patient safety is a top priority and the company takes all reports about adverse events very seriously.
“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,” it said.