BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Anti-diabetics containing rosiglitazone: Order of discontinuation in Germany due to cardiovascular risks and Dear Doctor Letter (Rote-Hand-Brief)

Active substance: rosiglitazone

In a decision dated 23 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the recall of anti-diabetics containing rosiglitazone from the trade chain in Germany down to the pharmacy level. Due to the necessity of switching patients to other medications, the recall is to become effective on 1 November 2010. This decision is based on the scientific conclusions of the Committee for Human Medicinal Products (CHMP) which has come to a negative risk-benefit ratio for these medicinal products because of cardiovascular risks and recommends suspension of their marketing authorisations.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 238KB, File is accessible