The European Medicine Agency (EMA) will be reviewing Novo Nordisk’s popular diabetes drug, Ozempic, for potential suicide ideation and self-harming risk.
After two incidents from patients in Iceland, the regulator’s Pharmacovigilance Risk Assessment Committee (PRAC) revealed that it would look into the adverse events and look to determine if the events were related to the drug. The PRAC will also be looking into all GLP-1 class drugs, including Novo's Saxenda (liraglutide) and Wegovy (semaglutide).
The drug, approved to treat diabetes, has dominated headlines as celebrities and internet influencers sang its praises when used off-label as a weight loss drug. The demand, coupled with some CMO-related manufacturing snags, has caused a shortage of both Novo Nordisk's semaglutides — Ozempic and the version actually approved for weight loss, Wegovy.
Ozempic has six other disease interactions listed, including thyroid cancer, GI adverse events, hypoglycemia, pancreatitis and retinopathy.