European drug safety officials have initiated an investigation into the diabetes medication Ozempic due to reports of patients experiencing thoughts of suicide or self-harm. The European Medicines Agency (EMA) launched the probe after the health regulator in Iceland raised concerns about three cases involving patients contemplating suicide or engaging in self-harming behavior. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will also investigate weight-loss drugs Wegovy and Saxenda.
Ozempic is designed to mimic the hormone glucagon-like peptide-1 (GLP-1), which targets specific areas of the brain responsible for appetite and food intake regulation. The PRAC will evaluate the risks associated with weight-loss medications containing semaglutide or liraglutide, both of which are GLP-1 agonists that induce weight loss by reducing energy intake.
The rising popularity of weight-loss drugs has led to increased demand for quick-fix solutions for obesity, partly due to the promotion of these drugs by influencers and celebrities. Saxenda and Wegovy have received approval for weight loss in the UK and the US. Although Wegovy is not currently available in the UK, the Prime Minister has announced that physicians will be able to offer it to patients for diabetes and weight management.
CNN Reported that according to an EMA official speaking to the BBC, the review is being conducted in response to a signal procedure initiated by the Icelandic Medicines Agency, prompted by three case reports. A signal procedure refers to information about a potential adverse event associated with a medication, whether it is already known or newly identified, that necessitates further investigation. The EMA official stated that the case reports included two instances of suicidal thoughts, one following the use of Saxenda and another after using Ozempic. An additional case involved thoughts of self-injury associated with Saxenda. The EMA will provide further updates as more information becomes available.
The medications in question include suicidal thoughts or depression in their list of side effects, along with other symptoms such as nausea, vomiting, headaches, and constipation. Patients are advised to be vigilant for any mental changes, particularly sudden shifts in mood, behavior, thoughts, or feelings. The leaflet accompanying the drugs emphasizes the importance of promptly contacting a healthcare provider in case of any new, worsening, or concerning mental changes.
Novo Nordisk, the leading healthcare company manufacturing all three weight-loss drugs, stated that it remains committed to ensuring patient safety. The company defended the use of semaglutide and liraglutide, stating that GLP-1 receptor agonists have been used for over 15 years to treat type 2 diabetes and for obesity treatment for 8 years. Novo Nordisk highlighted that their products, including semaglutide and liraglutide, have been available in the UK market since 2018 and 2009, respectively.
The company emphasized that safety data collected from extensive clinical trials and post-marketing surveillance have not indicated a causal link between semaglutide or liraglutide and suicidal or self-harming thoughts. Novo Nordisk continues to monitor data from ongoing clinical trials and real-world use of their products and maintains close collaboration with authorities to ensure patient safety and provide adequate information to healthcare professionals.
The Medicines and Healthcare products Regulatory Agency (MHRA), the drug regulator in the UK, is also monitoring the developments regarding these drugs. Alison Cave, the Chief Safety Officer of the MHRA, urged users to report any side effects experienced with these medications and to seek immediate medical assistance in case of suicidal or self-harm thoughts.
