The European Medicines Agency said Monday it would undertake a review into a number of drugs used to treat obesity and diabetes after it was reported some patients experienced thoughts of suicide or self-harm.
In a statement, the regulator said its safety committee, or PRAC, was "currently evaluating the risk of suicidal thoughts and thoughts of self-harm in patients who used a semaglutide — or liraglutide —containing 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 new or known adverse event that is potentially caused by a medicine and that warrants further 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 authorised for weight loss, together with diet and physical activity," the EMA said.
Ozempic is used to treat type 2 diabetes, and its active ingredient is semaglutide. All drugs are manufactured by Danish firm Novo Nordisk.
Shares of the company were slightly higher on Monday afternoon, paring earlier losses.
"Suicidal behaviour 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 also include other medicines of the same class ('GLP-1 receptor agonist')."
In a statement sent to CNBC, Novo Nordisk said, "Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines 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 added.
"The safety data collected from large clinical trial programs and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts."
The business said that it was "continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals."
"EMA continuously monitors for safety signals and so does Novo Nordisk," it said. "Novo Nordisk remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety."
If you are having suicidal thoughts, contact the Suicide & Crisis Lifeline in the U.S. at 988 or the Samaritans in the U.K. at 116 123.