A small dose

NOVO NORDISK RESPONDS TO EMA REVIEW OF GLP-1 DRUGS

NovoNordisk’s diabetes and obesity medication, specifically Ozempic (semaglutide) and Saxenda (liraglutide), have come under scrutiny following two reports of suicidal thoughts and one case of self-harm in Iceland. This has prompted a European Medicines Agency (EMA) review into both drugs.

The aim of the review, conducted by the Pharmacovigilance Risk Assessment Committee, will explore the casual links between Saxenda and Ozempic to determine whether there is a link between taking the medication and the potentially adverse effects that some patients have experienced.

GLP-1 treatments have increased in popularity over the last few years due to their ability to encourage dramatic weight loss. A recent report from BMJ suggested that: Among patients with weight measures available, 33.4% and 43.5% achieved clinically meaningful weight loss ≥5% of baseline weight at 12 and 24 months, respectively. At 24 months, 59.2% and 64.7% of patients with T2DM were adherent to or discontinued GLP-1 RA therapy, respectively.

Given that the risks attached to the use of semaglutide (Ozempic) for those with mental health difficulties, predominantly use of semaglutide (Wegovy) for weight loss, should be avoided in patients with a history of suicidal attempts or active suicidal ideation, there is a likelihood that the drug may face harsher scrutiny. Worthwhile remembering that the EMA have suggested that it may expand its review to encompass an analysis of all GLP-1 drugs.

Having reached out to Novo Nordisk for comment, a spokesperson stated: “Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously. GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide and liraglutide that have been on the market for more than 10 years. The safety data collected from large clinical trial programs and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts. Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals. EMA continuously monitors for safety signals and so does Novo Nordisk. Novo Nordisk remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”