European regulators probe risks of suicidal thoughts in users of popular weight-loss medications
CNN
By Meg Tirrell, CNN
(CNN) — The European Medicines Agency’s safety committee is looking into the risk of suicidal thoughts and thoughts of self-harm in patients who used popular medicines for weight loss, like Ozempic, the regulator told CNN Monday.
The review comes after three case reports raised by the Icelandic Medicines Agency, the regulator said by email. Two were cases of suicidal thoughts, one following the use of Ozempic and another after use of another drug, called Saxenda. The third case involved thoughts of self-injury with Saxenda, the EMA said.
Ozempic, which contains the drug semaglutide, is cleared for type 2 diabetes, while Saxenda contains a similar drug called liraglutide and is approved for chronic weight management. Both are made by Novo Nordisk.
The EMA notes that suicidal behavior isn’t currently listed as a side effect in the European Union product information for the medicines and said its safety committee will consider whether the review should extend to other medicines in the class, known as GLP-1 receptor agonists. The group includes Wegovy, the version of semaglutide approved for chronic weight management, and Mounjaro, a drug from Eli Lilly currently approved for diabetes.
Novo Nordisk told CNN on Monday that “patient safety is a top priority” and said it takes “all reports about adverse events from use of our medicines very seriously.”
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 been surging 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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