European regulator expands investigation into risks of suicidal thoughts in users of popular weight-loss medications
By Meg Tirrell, CNN
(CNN) — European regulators said Tuesday that they’d broadened an investigation started last week into the risk of suicidal thoughts among patients taking popular drugs for weight loss, like Ozempic, to include more potential cases and other medicines in the class.
The European Medicines Agency is now evaluating about 150 reports of possible cases of self-injury and suicidal thoughts, the regulator said in a statement Tuesday.
On Monday, the regulator told CNN that it had opened a probe after reports of three cases of suicidal thoughts and thoughts of self-harm flagged by the Icelandic Medicines Agency.
The EMA said it’s not yet clear whether the medicines caused the events or whether they’re linked to patients’ underlying conditions or other factors.
The first three cases were reported among people taking Ozempic, which is approved for type 2 diabetes but used off-label for weight loss, and Saxenda, cleared for weight loss, the EMA said Monday.
The EMA said the investigation was opened July 3, and it expects it to conclude in November.
Ozempic contains the medicine semaglutide, which is also the active ingredient in its sister drug, Wegovy, which is cleared for weight loss. Saxenda contains a similar drug called liraglutide. All three are made by Novo Nordisk.
The company told CNN on Monday that “patient safety is a top priority” and that it takes “all reports about adverse events from use of our medicines very seriously.”
The EMA notes that suicidal behavior isn’t currently listed as a side effect in the European Union product information for the medicines.
They’re all part of a class known as GLP-1 receptor agonists, which also includes the type 2 diabetes drug Mounjaro, made by Eli Lilly – also used off-label for weight loss while it awaits regulatory clearance for that use. The EMA told CNN Wednesday that the safety review doesn’t include tirzepatide, the drug in Mounjaro, as it targets a second hormone, GIP, in addition to GLP-1. The review comprises semaglutide, liraglutide, lixisenatide, dulaglutide and exenatide.
The US prescribing information for Saxenda includes 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 people on the drug, of more than 3,300, reported suicidal ideation, compared with two of more than 1,900 on a placebo. One adult on Saxenda attempted suicide, the prescribing information says. In pediatric clinical trials, one person on Saxenda died by suicide, of 125 studied. 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, although the information for Wegovy notes that suicidal behavior and ideation have been reported in clinical trials with other weight management products and says patients should be monitored for depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.
The US Food and Drug Administration told CNN on Monday that it “routinely evaluates individual adverse event reports and adverse event reports from the published literature for all approved drugs” and doesn’t comment on third-party research or individual reports “as a general matter.” The agency said it continues to monitor the safety of medicines post-approval and has a system of surveillance and risk-assessment programs, and if new safety signals are identified, it will determine which steps to take.
In 2008, the weight loss drug Acomplia, made by French drugmaker Sanofi, was pulled from the European market over concerns about suicidal thoughts. The drug, which works in a different way than GLP-1 medicines, was never cleared in the US.
These newer weight loss medications have surged in popularity. They work by mimicking the effects of an appetite-regulating hormone called GLP-1. They stimulate the release of insulin, which helps lower blood sugar, and slow the passage of food through the gut. The FDA approved semaglutide for diabetes as Ozempic in 2017 and for weight loss as Wegovy in 2021.
The drugs have known gastrointestinal side effects like nausea, vomiting and diarrhea.
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