European drug safety officials opened an investigation recently regarding Ozempic after patients receiving the popular weight-loss injections 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 is generally intended to treat diabetes after Iceland’s health regulator reported three cases of users considering suicide or self-harm.
In addition to the type-2 diabetes shot, weight loss medications Wegovy and Saxenda will also be investigated by EMA’s drug risk assessment committee (PRAC).
A popular medicine worldwide and in Israel
Ozempic works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) which targets areas of the brain that regulate appetite and food intake.
The committee will evaluate the risks of slimming drugs containing semaglutide or liraglutide, GLP-1 agonists that induce weight loss by reducing energy intake.
The investigation comes as the popularity of weight loss drugs has led to a rise in demand for a quick-fix treatment for obesity, with influencers and celebrities promoting their use.
These injections are so popular in Israel and worldwide that sometimes there are shortages due to the growing demand.
An EMA official told the BBC that testing is being carried out as part of a procedure brought up by the Icelandic Medicines Agency, following these three cases.
Warnings on the leaflet inserted with each injection tell people that they should be alert to mental changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Patients need to contact their doctor immediately if they feel any mental changes that weren’t there, are worse, or worry them.
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 liraglutide.
The company told the British Independent that GLP-1 receptor agonists have been used to treat type-2 diabetes for over 15 years and to treat obesity for eight years, including Novo Nordisk products like semaglutide and liraglutide which have been on the UK market since 2018 and 2009 respectively.
Safety data gathered from large clinical trials and post-marketing surveillance didn’t show a causal relationship between suicidal thoughts and self-harm.
Novo Nordisk also said that they continuously monitor data from ongoing clinical trials and real-world use of its products and work closely with authorities to ensure patient safety and that adequate information is given to healthcare professionals.