The European Medicine Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) reported this week that they found no evidence of a connection between glucagon-like peptide-1 (GLP-1) receptor agonists and suicidal thoughts.
In their latest meetings, the PRAC concluded that there is no evidence to suggest a causal relationship between these diabetes and weight management drugs — including popular brands like Ozempic, Rybelsus and Wegovy — and increased risk of suicidal or self-injurious behavior.
This decision follows an extensive review which began in July 2023, after two patients in Iceland reported adverse events. The committee's findings were supported by recent studies using large health databases, which showed no significant link between the use of semaglutide and suicidal ideation.
The PRAC also discussed a new dosage line for Rybelsus tablets, advising on communication strategies for healthcare providers about the product's new formulations.
Ozempic, widely known for its diabetes treatment, gained significant media attention as celebrities and internet influencers praised its off-label use for weight loss. However, this surge in demand led to shortages, exacerbated by manufacturing issues. Additionally, Ozempic is noted for having interactions with six other diseases, including thyroid cancer, gastrointestinal adverse events, hypoglycemia, pancreatitis and retinopathy.