European regulators probe risks of suicidal thoughts in users of popular weight-loss medications

European regulators probe risks of suicidal thoughts in users of popular weight-loss medications


CNN reported that the European Medicines Agency safety committee is investigating the possibility of suicidal and self-harming thoughts in patients who use popular weight loss medicines, such as Ozempic.

Icelandic Medicines Agency confirmed the review via email. The two cases involved suicidal thinking, with one case occurring after the use of Ozempic, and the other following use of Saxenda. According to the EMA, a third case involved thoughts of self-injury after taking Saxenda.

Ozempic contains semaglutide which is approved to treat type 2 diabetes. Saxenda, on the other hand, contains liraglutide a drug similar and has been approved to manage chronic weight. Both products are manufactured by Novo Nordisk.

The EMA noted that suicidal behaviour is not currently listed in the EU product information for the medicines. It said its safety panel will examine whether the review should be extended to other medicines of the same class, also known as GLP-1 agonists. Wegovy is the version of semaglutide that has been approved for chronic weight loss, as well as Mounjaro from Eli Lilly, which is currently approved for diabetes.

Novo Nordisk did not immediately respond to a request for comment.

In the US, prescribing information on Saxenda includes a recommendation that patients be monitored for suicidal or depression thoughts and discontinue Saxenda if these symptoms occur. In clinical trials, 9 of 3,300 patients taking the drug reported suicidal thoughts, compared to 2 of 1,900 placebo-treated adults. The prescribing information states that one adult patient taking Saxenda tried to commit suicide. One patient who took Saxenda in pediatric clinical trials died by suicide out of 125 patients studied. In the prescribing information, it says that 'insufficient information was available to establish a causal link to Saxenda'

The prescribing information of Ozempic in the US does not contain a similar warning, but the Wegovy information notes that suicidal behaviors and thoughts have been reported during clinical trials using other weight-management products. Patients should be monitored closely for any changes in mood, behavior or attitude, including depression.

CNN reported that the US Food and Drug Administration said it "routinely evaluates adverse event reports and reports of adverse events from published literature" and does not comment on individual reports or third-party reports "as a matter of general concern." The FDA said that it monitors the safety of drugs after approval and has programs for surveillance and risk assessment. If new safety signals are detected, it will decide what to do.

Acomplia was withdrawn from the European market in 2008 due to concerns over suicidal thinking. The drug was never approved in the US, as it works differently than GLP-1 medications.

Popularity of these newer weight-loss medications is surging. These medications mimic the effects of a hormone that regulates appetite called GLP-1. They increase insulin release, which lowers blood sugar and slows the passage of food in the intestine. FDA approved semaglutide in 2017 for weight loss and diabetes as Wegovy.

These drugs can cause nausea, vomiting, and diarrhea.