In this photo illustration, boxes of the diabetes drug Ozempic are displayed at a pharmacy counter in Los Angeles, April 17, 2023.
Mario Tama | Getty Images
The European Union’s drug regulator said this on Tuesday expanded research on the risk of suicidal thoughts and self-harm in patients using it Novo Nordisk‘s Ozempic, Wegovy and Saxenda drugs to include other weight loss and diabetes drugs.
The European Medicines Agency did not specify which additional drugs are now included in the study, but it could potentially include Eli Lilly‘s diabetes drug Mounjaro, that is approved in the EU. Other companies such as Pfizer And Amgen develop similar products.
The EMA said it is now evaluating about 150 reports of possible cases of self-harm and suicidal ideation in patients taking medications for weight loss and diabetes. It is still unclear whether the drugs caused the events or whether they are related to the patient’s underlying conditions or other factors, the statement said.
The EMA expects to complete its investigation in November, a statement said.
On Monday, the agency told CNBC it had launched an investigation into the matter following the Icelandic Medicines Agency reported three cases of suicidal ideation and self-harm in patients taking medicines containing liraglutide and semaglutide.
Liraglutide is the active ingredient in Saxenda, the weight loss drug from Novo Nordisk. Semaglutide is the active ingredient in the weight loss injection from the Danish company, Wegovy, and its diabetes counterpart, Ozempic.
Liraglutide and semaglutide are part of a class of very popular drugs called GLP-1 receptor agonists.
They mimic a hormone produced in the gut called GLP-1 to suppress a person’s appetite and ultimately aid weight loss. Those drugs can also help people manage type 2 diabetes because they stimulate the release of insulin from the pancreas, which lowers blood sugar levels.
Novo Nordisk said in a statement to CNBC Monday that “safety data collected from large clinical trial programs and post-marketing surveillance have not established a causal relationship between semaglutide or liraglutide and suicidal ideation and self-harm.”
The company said it is “constantly monitoring data from ongoing clinical trials and real-world use of its products and is working closely with authorities to ensure patient safety and adequate information for healthcare professionals.”
The EMA’s investigation could potentially reveal new side effects linked to blockbuster drugs such as Wegovy and Ozempic, which are already known to cause nausea, vomiting and diarrhoea.
Suicidal behavior is not currently listed as an adverse reaction in the EU product information for GLP-1 receptor agonists.
The United States prescribing information Novo Nordisk’s Saxenda, approved by the Food and Drug Administration, also does not list suicidal ideation or self-harm as side effects. But it does include a recommendation to monitor patients for depression or suicidal thoughts and to discontinue the drug if symptoms develop.
Clinical trials in adults found that nine of the 3,300 people on Saxenda reported suicidal ideation. That’s compared to two of more than 1,900 people on a placebo. The prescribing information says “there was insufficient information to establish a causal relationship to Saxenda.”
There is no similar warning in the US prescribing information for Ozempic.
Wegovy’s US prescribing information reports suicidal ideation and behavior in clinical trials for other weight management products. Patients on Wegovy should be monitored for depression and suicidal thoughts or behavior, the information says.
If you are having suicidal thoughts, please contact the Suicide and crisis lifeline in the US on 988 or the Samaritans in the UK on 116 123.