European drug safety officials opened an investigation into Ozmpic after patients receiving the popular weight-loss injection in Israel also reported thoughts of suicide or self-harm.
On July 10, the European Medicines Agency (EMA) told Reuters it was investigating negative side effects of the popular drug, which was originally intended for diabetes, after Iceland's health regulator reported three cases of users considering suicide or self-harm.
As well as the type 2 diabetes injection, weight loss drugs Wegovy and Saxenda will also be investigated by the Authority's Medicines Risk Assessment Committee (PRAC).
Ozampic works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The committee will evaluate the risks of weight loss drugs containing semaglutide or liraglutide, GLP-1 agonists that induce weight loss by reducing energy intake.
The investigation comes as the popularity of slimming drugs has led to a rise in demand for a quick treatment for obesity, with influencers and celebrities promoting their use. These injections are also very popular in Israel, and as in the world - sometimes there is a shortage of injections due to the growing demand.
An EMA official told the BBC that the test "is being carried out in the context of a signaling procedure put in place by the Icelandic Medicines Agency, following these three cases". "You should pay attention to mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your doctor immediately if you feel mental changes that were not there, are worse, or that worry you," reads a warning on the drug leaflet. Leading healthcare company Novo Nordisk, which makes all three weight-loss drugs, said it "remains committed to ensuring patient safety", but defended the use of semaglutide and biliraglutide. "GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and to treat obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide which have been on the UK market since 2018 and 2009 respectively," Novo Nordisk told The Independent " the British.
Safety data collected from large clinical trial programs and post-marketing surveillance did not demonstrate a causal relationship between semaglutide or liraglutide and suicidal ideation and self-harm. Novo Nordisk continuously 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."