EU expands Wegovy, Ozempic study on suicide risks to include other weight loss and diabetes drugs

The European Union medicines regulator announced on Tuesday that it expanded the investigation in the risk of suicidal thoughts and self-harm among patients taking Novo NordiskOzempic, Wegovy, and Saxenda, among others weight loss and diabetes medicines.

The European Medicines Agency did not specify which additional drugs are now included in the investigation. But it can potentially include Eli Lillydiabetes medicine Mounjaro which is approved in the EU. Other companies, such as Pfizer and Amgen develop similar products.

The EMA said it is now assessing around 150 reports of possible cases of self-harm and suicidal thoughts in patients taking weight loss and diabetes medicines. It remains unclear whether the drugs caused the events or were related to the patients’ underlying illnesses or other factors, the statement said.

The EMA expects to complete the investigation in November, it said in a statement.

On Monday, the agency told CNBC has launched an investigation into the matter after it Icelandic Medicines Agency characterized three cases of suicidal ideation and self-harm in patients taking drugs containing liraglutide and semaglutide.

Liraglutide is the active ingredient in Novo Nordisk’s weight loss medicine Saxenda. Semaglutide is the active ingredient in the Danish weight loss injection, 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 help with weight loss. These drugs can also help people manage type 2 diabetes by stimulating the release of insulin from the pancreas and lowering blood sugar levels.

Novo Nordisk said in a statement to CNBC on Monday that “safety data collected from large clinical trial programs and post-marketing surveillance did not demonstrate a causal relationship between semaglutide or liraglutide and suicidal and self-harm thoughts.”

The company said it “continually monitors data from ongoing clinical trials and real-world use of its products and works closely with authorities to ensure patient safety and appropriate information for healthcare professionals.”

The EMA 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 a side effect in the EU product information for any GLP-1 receptor agonist.

USA prescribing information for Novo Nordisk Saxenda, which is approved by the Food and Drug Administration, also does not list suicidal thoughts 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 occur.

Clinical trials in adults found that nine out of 3,300 people on Saxenda reported suicidal thoughts. That’s compared to two out of more than 1,900 people on a placebo. The prescribing information states that “there was insufficient information to establish a causal relationship with Saxenda.”

There is no similar warning in the US prescribing information for Ozempic.

The U.S. prescribing information for Wegovy states that suicidal thoughts and behaviors have been reported in clinical trials of 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 Suicide and Crisis Helpline in the USA at 988 or Samaritans in the UK on 116 123.