Europe's drugs regulator has been alerted to a possible link to thoughts of suicide among some users.
Depression or thoughts of suicide is listed in the product-information leaflet, which advises users: "You should pay attention to any mental changes, especially sudden changes in your mood, behaviours, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you."Manufacturer Novo Nordisk is working with the EMA and says patient safety is a top priority.
"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."Novo Nordisk remains committed to ensuring patient safety."
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