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In this photo illustration, boxes of diabetes medicine Ozempic are on a pharmacy counter in Los Angeles, April 17, 2023.
Mario Tama | Getty Images
The European Union’s medicines regulator said on Tuesday it had done so Expand the investigation at risk of suicidal thoughts and self-harm among patients who take Novo NordiskOzempic, Wegovy, and Saxenda include other medications for weight loss and diabetes.
the European Medicines Agency Additional medications that are now included in the investigation have not been identified, but are likely to be Eli LillyMonjaro Diabetes Medication, which is approved in the European Union. Other companies like Pfizer And Amgen You are developing similar products.
The agency said it is now evaluating about 150 reports of possible self-harm and suicidal thoughts in patients taking weight-loss and diabetes medications. It remains unclear whether the drugs caused the events, or if they were related to the patients’ underlying conditions, or to other factors, the statement said.
EMA is expected to complete its investigation in November, according to a statement.
On Monday, the agency told CNBC that it had yet to open an investigation Icelandic Medicines Agency Three cases of suicidal thoughts and self-harm were reported in patients taking liraglutide and semaglutide-containing drugs.
Liraglutide is the active ingredient in Novo Nordisk’s Saxenda slimming drug. Semaglutide is the active ingredient in the Danish company’s weight loss injections, Wegovy, and its diabetic counterpart, Ozempic.
Liraglutide and semaglutide are part of a very popular class of medications 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 medications 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 on Monday that “safety data collected from large clinical trial and post-marketing surveillance programs did not show a causal association between semaglutide or liraglutide and suicidal thoughts and self-harm.”
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 adequate information for healthcare professionals.”
Achieving EMA could trigger new side effects associated with blockbuster drugs like Wegovy and Ozempic, which are already known to cause nausea, vomiting, and diarrhea.
Suicidal behavior is not currently listed as a side effect in the EU product information for any GLP-1 receptor agonists.
United State Description of information For Saxenda from Novo Nordisk, which is approved by the Food and Drug Administration, suicidal thoughts or self-harm are also not listed as side effects. But it does include a recommendation to monitor patients for depression or suicidal thoughts and to stop taking the medication if symptoms appear.
Clinical trials in adults found that nine of the 3,300 people on Saxenda reported having suicidal thoughts. This compared to two people out of more than 1,900 people taking a placebo. The prescribing information says, “There was not enough information to establish a causal relationship with Saxenda.”
There is no similar warning in the United States Description of information for ozimbek.
US Wegovy’s prescribing information refers to suicidal thoughts and behavior reported in clinical trials of other weight management products. The information says Wegovy patients should be monitored for depression and suicidal thoughts or behavior.
If you have suicidal thoughts, call Suicide and crisis lifeline in the United States at 988 or Samaritans in the UK at 116,123.
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