What PMDA published
On 30 October 2026, PMDA published proper-use information for GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists. The notice responds to use for cosmetic or simple weight-loss purposes outside treatment of type 2 diabetes and approved obesity indications.
Off-label boundary
Safety and efficacy for off-label cosmetic weight-loss use have not been established. Approved indications, dosing and administration must be followed. The notice is not a withdrawal of approval or a ban on the drug class.
Ketosis-related reports
Multiple reports involved excessive dietary restriction, frequent vomiting, inability to move, emergency transport and a diagnosis of ketosis. Worsening ketosis can progress to ketoacidosis with impaired consciousness and life-threatening consequences.
Other risks
Hypoglycaemia, acute pancreatitis, nausea, vomiting and diarrhoea also require attention. Persistent vomiting or inability to eat or drink requires prompt medical assessment.
International-patient and health-management use
Patients should verify the exact product, Japanese indication, prescriber, dose, testing, nutrition plan, concomitant medicines and follow-up system rather than choosing a clinic based only on advertised weight loss.