EU expands Ozempic probe over suicide risks
EU expands Ozempic probe over suicide risks

In this photo, boxes of the diabetes drug Ozempic are displayed on the counter of a pharmacy on April 17, 2023 in Los Angeles, California.

Mario Tama | Getty Images

The European Union’s medicines watchdog said on Tuesday that it had Expand the scope of the investigation Investigating the risk of suicidal thoughts and self-harm in patients taking the drug Novo NordiskThe Ozempic, Wegovy and Saxenda medicines include other weight loss and diabetes medicines.

this European Medicines Agency It did not specify which other drugs are now included in the investigation.but it may include Eli Lillydiabetes drug Mounjaro, EU approval.other companies such as Pfizer and Amgen Similar products are being developed.

The EMA said it was currently reviewing around 150 reports of possible self-harm and suicidal thoughts in patients taking weight-loss and diabetes drugs. It is unclear whether the drugs caused the events, or whether they were related to the patient’s underlying disease or other factors, the statement said.

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

On Monday, the agency told CNBC it opened an investigation into the matter after the incident. Icelandic Medicines Agency flagged three cases of suicidal thoughts and self-harm in patients taking a drug containing liraglutide and semaglutide.

Liraglutide is the active ingredient in Novo Nordisk’s weight-loss drug Saxenda. Semaglutide is the active ingredient in the Danish company Wegovy, a slimming injection, and its diabetes injection, Ozempic.

Liraglutide and semaglutide belong to a very popular class of 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 in weight loss. These drugs can also help people manage type 2 diabetes because they stimulate the pancreas to release insulin, which lowers blood sugar levels.

In a statement to CNBC on Monday, Novo Nordisk said, “Safety data collected from large clinical trial programs and post-marketing surveillance do not show a significant link between semaglutide or liraglutide and thoughts of suicide and self-harm. There is a causal relationship.”

The company said it is “continuously monitoring data from ongoing clinical trials and actual use of its products, and working closely with authorities to ensure patient safety and adequate information to healthcare professionals.”

The EMA’s investigation may uncover new side effects linked to blockbuster drugs such as Wegovy and Ozempic, which are known to cause nausea, vomiting and diarrhoea.

Currently, suicidal behavior is not listed as a side effect in any EU product information for GLP-1 receptor agonists.

U.S. prescribing information Novo Nordisk’s Saxenda, which is FDA-approved, also doesn’t list suicidal thoughts or self-harm as side effects. But it does include recommendations to monitor patients for depression or suicidal thoughts and to stop the medication if symptoms develop.

A clinical trial in adults found that 9 of 3,300 patients on Saxenda reported suicidal ideation. In contrast, only two of the more than 1,900 people received a placebo. The prescribing information says “There was insufficient information to determine a causal relationship with Saxenda.”

There are no similar warnings in the US prescribing information for ozone.

The U.S. prescribing information for Wegovy states that suicidal ideation and behavior have also been reported in clinical trials of other weight management products. Patients using Wegovy should be monitored for depression and suicidal thoughts or behavior, the information said.

If you are having suicidal thoughts, please contact Suicide and Crisis Lifeline Dial 988 in the US or Samaritan United Kingdom: 116 123.


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