EU expands Ozempic investigation into suicide dangers

Boxes of the diabetes drug Ozempic are pictured on display at a pharmacy counter in Los Angeles April 17, 2023.

Mario Tama | Getty Images

The European Union medicines agency said on Tuesday it had expanded an investigation into the risk of suicidal thoughts and self-harm in patients taking medication Novo Nordisk‘s Ozempic, Wegovy, and Saxenda drugs to include other weight-loss and anti-diabetic drugs as well.

The European Medicines Agency did not say which additional medicines are now included in the investigation, but it could potentially be Eli LillyThe diabetes drug Mounjaro, approved in the EU. Other companies such as Pfizer And amgen develop similar products.

EMA said it is currently reviewing around 150 reports of possible cases of self-harm and suicidal thoughts in patients taking weight-loss and diabetes medicines. It is still unclear whether the drugs caused the events or whether they are related to the patients’ underlying medical conditions or other factors, the statement said.

According to a statement, EMA expects to complete its investigation in November.

On Monday, CNBC said it had opened an investigation into the matter after the Icelandic Medicines Agency reported three cases of suicidal thoughts and self-harm in patients taking liraglutide and semaglutide drugs.

Liraglutide is the active ingredient in Novo Nordisk’s weight loss drug Saxenda. Semaglutide is the active ingredient in the Danish company’s weight loss syringe Wegovy and its diabetes counterpart Ozempic.

Liraglutide and semaglutide belong to 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 because they increase the release of insulin from the pancreas, thereby lowering blood sugar levels.

Novo Nordisk told CNBC in a statement on Monday that “safety data from large clinical trial programs and post-market surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts.”

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

EMA’s investigation could potentially uncover new side effects linked to blockbuster drugs like Wegovy and Ozempic, which are already known to cause nausea, vomiting and diarrhea.

Suicidal behavior is not currently listed as an adverse reaction in the EU product information for any GLP-1 receptor agonist.

The U.S. prescribing information for Novo Nordisk’s Saxenda, which is approved by the Food and Drug Administration, also does not list suicidal thoughts or self-harm as a side effect. However, it does recommend monitoring patients for depression or suicidal thoughts and stopping the drug if symptoms appear.

Clinical studies in adults found that nine out of every 3,300 people on Saxenda had suicidal thoughts. In comparison, two out of more than 1,900 people received a placebo. The prescribing information states: “There was insufficient information to establish a causal relationship with Saxenda.”

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

Wegovy’s US prescribing information notes that suicidal thoughts and behaviors have been reported in clinical trials for other weight management products. According to the information, patients taking Wegovy should be monitored for depression and suicidal thoughts or behavior.

If you are having suicidal thoughts, call the US Suicide & Crisis Lifeline on 988 or the Samaritans in the UK on 116 123.

Comments are closed.