Publications

Published: March 2011

Suspension of rosiglitazone (Avandia and Avandamet) in New Zealand

Prescriber Update 32(1): 1
March 2011

In December 2010 the Medicines Adverse Reactions Committee (MARC) recommended that the consent to distribute rosiglitazone-containing medicines be suspended in New Zealand from 29 April 2011.

The recommendation follows the MARC review of the benefits and risks of treatment with rosiglitazone. Rosiglitazone has been under regular review by the MARC since 2005.

Of particular concern to the MARC and Medsafe was the potential for rosiglitazone to cause myocardial infarction; a risk not known to be associated with other medicines in the class.

The MARC considered that data from metaanalyses and observational studies demonstrated an increased risk of myocardial infarction and that action was warranted. Although the results from the RECORD study did not show the same risk, this study was limited by its open-label design.1 For this reason the MARC recommended that the consents for rosiglitazone-containing medicines be suspended rather than revoked.

The suspension will remain in place until the company that developed rosiglitazone identifies a population of patients for whom the benefits of treatment outweigh the risks. Medsafe has advised patients not to stop taking rosiglitazone; but they should contact their doctor to discuss alternative treatments.

Further information on the rosiglitazone risk:benefit review and the MARC recommendations is available at: www.medsafe.govt.nz/profs/ adverse/Minutes144.htm#3.1

Summary and key messages:

  • The consent to distribute rosiglitazonecontaining medicines is to be suspended in New Zealand.
  • The suspension will take effect from 29 April 2011 to allow patients enough time to change treatment.
  • Patients should not stop taking rosiglitazone, but should contact their prescriber to discuss alternative treatments.
Reference
  1. Home PD, Pocock SJ, Beck-Nielsen H et al. 2009. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. The Lancet 373 (9681):2125-35.