Sibutramine containing medicines: implementation of European Commission decision to suspend marketing authorisation due to increased risk of cardiovascular events
2019.10.04
Active substance: sibutramine
On 30 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) ordered the implementation of the European Commission's decision on drugs containing sibutramine and the increased risk of cardiovascular events. The reason for this decision is the evaluation of the Sibutramine Cardiovascular Outcome (SCOUT) study. The pharmaceutical entrepreneur had previously decided on his own responsibility not to market his appetite suppressant. In a letter dated 13 September 2019, the BfArM again ordered the further suspension of the marketing authorisations.
To the risk assessment procedure (available in German only)
For further information please click on the following link to the homepage of the European Medicines Agency (EMA):