Packages of the weight-loss drug Wegovy from the pharmaceutical company Novo Nordisk lie on the sales counter in a Danish pharmacy.
Stefan Trumpf | Picture Alliance | Getty Images
The European Medicines Agency is to undertake a review into a number of drugs used to treat obesity and diabetes, according to Reuters, after it was reported some patients had experienced thoughts of suicide or self-harm.
Reuters said Monday that the regulator was looking at Novo Nordisk’s Ozempic, which is used to treat type 2 diabetes, and weight-loss drug Saxenda.
Shares of the Danish drugmaker were slightly higher on Monday afternoon, paring earlier losses.
A separate report from the BBC said the EMA would also review Novo Nordisk’s Wegovy which, like Saxenda, is used to aid weight-loss.
Both media outlets said the review would focus on products containing liraglutide or semaglutide. Saxenda’s active ingredient is liraglutide. The active ingredient in Wegovy and Ozempic is semaglutide.
Reports of the probe come after the Icelandic Medicines Agency notified the EMA of “three cases of patients on the drugs thinking about suicide or self-harm,” Reuters said.
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.”
The EMA was not immediately available to comment when contacted by CNBC.
