Europe's drugs regulator, the European Medicines Agency (EMA), is conducting a review of weight-loss injections due to a potential link to thoughts of suicide and self-harm among users. The review was prompted by three cases reported by Iceland's Medicines Agency. The medications under review include Wegovy, Saxenda, and similar drugs like Ozempic, which help reduce appetite. While product leaflets already list suicidal thoughts as a possible side effect, suicidal behavior is not currently listed for these prescription drugs.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will be conducting the review. Initially, the review will focus on weight-loss medications containing semaglutide or liraglutide. The Icelandic Medicines Agency reported two cases of suicidal thoughts associated with Saxenda and one case of self-injury thoughts with Saxenda. The EMA will provide further updates once more information becomes available.
The high demand for weight-loss treatments, often fueled by social media posts of celebrities shedding significant weight, has led to global shortages of Saxenda and Wegovy. While these medications are approved and licensed for weight loss, they also come with common side effects such as nausea, vomiting, headaches, and constipation. The product-information leaflet advises users to pay attention to any mental changes and contact their healthcare provider if they experience new or worsening mental changes.
The manufacturer, Novo Nordisk, emphasizes that GLP-1 receptor agonists, including semaglutide and liraglutide, have been used for years to treat diabetes and obesity without demonstrating a causal association with suicidal or self-harming thoughts. Novo Nordisk is committed to ensuring patient safety and collaborates closely with authorities to monitor safety signals.
The UK's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is also monitoring the situation and will communicate any new advice to healthcare professionals and patients if necessary. The MHRA encourages individuals experiencing suicidal thoughts or self-harm to seek immediate medical assistance and report any suspected side effects through their Yellow Card scheme.