Ozempic and Wegovy are being examined for suicide threats
July 11, 2023: On Monday, the European Medicines Agency said that it would undertake a review into several drugs used to treat obesity and diabetes after it was reported some patients shared thoughts of suicide or self-harm.
The regulator said its safety committee, or PRAC, was “currently evaluating the risk of suicidal ideas and thoughts of self-harm in patients who used a semaglutide or liraglutide medicine for weight loss.”
“The review is being carried out in the context of a signal procedure raised by the Icelandic Medicines Agency following three case reports,” the EMA said. “A signal is information on a recent or known adverse event caused by a medicine and warrants investigation.”
The EMA said the case reports “included 2 cases of suicidal thoughts, one following the use of Saxenda and one after Ozempic. One additional case reported thoughts of self-injury with Saxenda.”
“The semaglutide-containing medicine Wegovy and the liraglutide-containing medicine Saxenda are authorized for weight loss, together with diet and physical activity,” the EMA said.
Ozempic treats type 2 diabetes, and its active ingredient is semaglutide. All drugs are manufactured by the Danish firm Novo Nordisk.
Shares of the company were slightly higher on Monday afternoon, paring earlier losses.
“Suicidal behavior is not currently listed as a side effect in the EU product information of these medicines,” the EMA said. “The PRAC will consider whether the review should be extended to include other medicines of the same class (‘GLP-1 receptor agonist’).”
“GLP-1 receptor agonists have been utilized to treat type 2 diabetes for over 15 years and for treatment of obesity for eight years, including Novo Nordisk products such as liraglutide and liraglutide that have been on the market for more than ten years,” it added.
“The safety data collected from large clinical trial programs and post-marketing management have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”
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