European drugs regulator to review Wegovy, Ozempic following reports of suicidal thoughts

The European Medicines Agency said Monday it would undertake a reappraisal into a fig of drugs utilized to dainty obesity and diabetes aft it was reported immoderate patients experienced thoughts of termination oregon self-harm.

In a statement, the regulator said its information committee, oregon PRAC, was "currently evaluating the hazard of suicidal thoughts and thoughts of self-harm successful patients who utilized a semaglutide — oregon liraglutide —containing medicine for value loss."

"The reappraisal is being carried retired successful the discourse of a awesome process raised by the Icelandic Medicines Agency pursuing 3 lawsuit reports," the EMA said. "A awesome is accusation connected a caller oregon known adverse lawsuit that is perchance caused by a medicine and that warrants further investigation."

The EMA said the lawsuit reports "included 2 cases of suicidal thoughts, 1 pursuing the usage of Saxenda and 1 aft Ozempic. One further lawsuit reported thoughts of self-injury with Saxenda."

"The semaglutide-containing medicine Wegovy and the liraglutide-containing medicine Saxenda are authorised for value loss, unneurotic with fare and carnal activity," the EMA said.

Ozempic is utilized to dainty benignant 2 diabetes, and its progressive constituent is semaglutide. All drugs are manufactured by Danish steadfast Novo Nordisk.

Shares of the institution were somewhat higher connected Monday afternoon, paring earlier losses.

"Suicidal behaviour is not presently listed arsenic a broadside effect successful the EU merchandise accusation of these medicines," the EMA said. "The PRAC volition see whether the reappraisal should beryllium extended to besides see different medicines of the aforesaid people ('GLP-1 receptor agonist')."

In a connection sent to CNBC, Novo Nordisk said, "Patient information is simply a apical precedence for Novo Nordisk, and we instrumentality each reports astir adverse events from usage of our medicines precise seriously."

"GLP-1 receptor agonists person been utilized to dainty benignant 2 diabetes for much than 15 years and for attraction of obesity for 8 years, including Novo Nordisk products specified arsenic semaglutide and liraglutide that person been connected the marketplace for much than 10 years," it added.

"The information information collected from ample objective proceedings programs and station selling surveillance person not demonstrated a causal relation betwixt semaglutide oregon liraglutide and suicidal and self-harming thoughts."

The concern said that it was "continuously performing surveillance of the information from ongoing objective trials and real-world usage of its products and collaborates intimately with the authorities to guarantee diligent information and capable accusation to healthcare professionals."

"EMA continuously monitors for information signals and truthful does Novo Nordisk," it said. "Novo Nordisk remains assured successful the payment hazard illustration of the products and remains committed to ensuring diligent safety."

If you are having suicidal thoughts, interaction the Suicide & Crisis Lifeline in the U.S. astatine 988 oregon the Samaritans in the U.K. astatine 116 123.