Packages of the weight-loss drug Wegovy from the pharmaceutical firm Novo Nordisk lie on the gross sales counter in a Danish pharmacy.
Stefan Trumpf | Image Alliance | Getty Photos
The European Medicines Company stated Monday it might undertake a assessment into quite a lot of medicine used to deal with weight problems and diabetes after it was reported some sufferers skilled ideas of suicide or self-harm.
In an announcement, the regulator stated its security committee, or PRAC, was “at the moment evaluating the chance of suicidal ideas and ideas of self-harm in sufferers who used a semaglutide — or liraglutide —containing medication for weight reduction.”
“The assessment is being carried out within the context of a sign process raised by the Icelandic Medicines Company following three case stories,” the EMA stated. “A sign is data on a brand new or recognized opposed occasion that’s doubtlessly brought on by a drugs and that warrants additional investigation.”
The EMA stated the case stories “included 2 circumstances of suicidal ideas, one following the usage of Saxenda and one after Ozempic. One extra case reported ideas of self-injury with Saxenda.”
“The semaglutide-containing medication Wegovy and the liraglutide-containing medication Saxenda are authorised for weight reduction, along with eating regimen and bodily exercise,” the EMA stated.
Ozempic is used to deal with kind 2 diabetes, and its lively ingredient is semaglutide. All medicine are manufactured by Danish agency Novo Nordisk.
Shares of the corporate have been barely greater on Monday afternoon, paring earlier losses.
“Suicidal behaviour isn’t at the moment listed as a facet impact within the EU product data of those medicines,” the EMA stated. “The PRAC will contemplate whether or not the assessment must be prolonged to additionally embrace different medicines of the identical class (‘GLP-1 receptor agonist’).”
In an announcement despatched to CNBC, Novo Nordisk stated, “Affected person security is a prime precedence for Novo Nordisk, and we take all stories about opposed occasions from use of our medicines very significantly.”
“GLP-1 receptor agonists have been used to deal with kind 2 diabetes for greater than 15 years and for remedy of weight problems for 8 years, together with Novo Nordisk merchandise similar to semaglutide and liraglutide which were in the marketplace for greater than 10 years,” it added.
“The security information collected from giant scientific trial packages and publish advertising and marketing surveillance haven’t demonstrated a causal affiliation between semaglutide or liraglutide and suicidal and self-harming ideas.”
The enterprise stated that it was “repeatedly performing surveillance of the information from ongoing scientific trials and real-world use of its merchandise and collaborates intently with the authorities to make sure affected person security and ample data to healthcare professionals.”
“EMA repeatedly screens for security indicators and so does Novo Nordisk,” it stated. “Novo Nordisk stays assured within the profit threat profile of the merchandise and stays dedicated to making sure affected person security.”
If you’re having suicidal ideas, contact the Suicide & Disaster Lifeline within the U.S. at 988 or the Samaritans within the U.Ok. at 116 123.
