Packets of the weight loss drug Wegovy from the pharmaceutical company Novo Nordisk sit on the sales counter of a Danish pharmacy.
Stefan Trumpf | Image Alliance | fake images
The European Medicines Agency said on Monday it would carry out a review of a number of drugs used to treat obesity and diabetes after it was reported that some patients experienced thoughts of suicide or self-harm.
In a statement, the regulator said its safety committee, or PRAC, was “currently assessing the risk of suicidal thoughts and thoughts of self-harm in patients using a semaglutide-containing or liraglutide-containing medicinal product for weight loss.”
“The review is taking place in the context of a procedure noted by the Icelandic Medicines Agency following three case reports,” the EMA said. “A signal is information about a new or known adverse event that is potentially caused by a drug and warrants further investigation.”
The EMA said the case reports “included 2 cases of suicidal thoughts, one after Saxenda use and one after Ozempic. One additional case reported thoughts of self-harm with Saxenda.”
“The semaglutide-containing medicine Wegovy and the liraglutide-containing medicine Saxenda are authorized for weight loss, along with diet and physical activity,” the EMA said.
Ozempic is used to treat type 2 diabetes and its active ingredient is semaglutide. All the drugs are manufactured by the Danish firm. new nordisk.
Shares of the company rose slightly on Monday afternoon, paring earlier losses.
“Suicidal behavior is not currently listed as a side effect in the EU product information for these medicines,” the EMA said. “The PRAC will consider whether the review should be extended to also include other medicinal products in the same class (‘GLP-1 receptor agonists’).”
In a statement sent to CNBC, Novo Nordisk said: “Patient safety is a top priority for Novo Nordisk, and we take all reports of adverse events arising from the 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 the treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide, which have been in the market for more than 10 years. added.
“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-harm thoughts.”
The company said it was “continually monitoring data from ongoing clinical trials and actual use of its products and is working closely with authorities to ensure patient safety and adequate information for healthcare professionals.”
“EMA continuously monitors security signals and so does Novo Nordisk,” he 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 Crisis and Suicide Lifeline in the US at 988 or samaritans in the UK on 116 123.
