Active substance
Sibutramine
- US FDA 1
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MERIDIA | 5MG; 10MG; 15MG | capsule · oral | ABBOTT | Discontinued | 22 Nov 1997 |
Safety signals and safety-related labeling changes
- EMA PRAC 2 Sep 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No - EMA PRAC 13 May 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No - EMA PRAC 6 Nov 2015 PRAC signal: New malformative risks in newborn and risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No - MHRA 11 Dec 2014 Sibutramine: suspension of EU licences recommended
Evidence indicates risks outweigh benefits.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.