Published: September 2010
Publications
Rosiglitazone and cardiovascular risk - current advice
Prescriber Update 31(3): 25
September 2010
Following international scrutiny of the risk of cardiovascular events in patients treated with rosiglitazone, prescribers are advised to carefully follow the contraindications, warnings, precautions and monitoring requirements for this medicine.1-3
Prescribers are reminded that rosiglitazone is not recommended for:
- Patients with symptomatic heart failure.
- Patients with acute coronary syndrome or ischaemic heart disease.
- Patients who are already receiving insulin.
Patients who are treated with rosiglitazone need to be monitored for signs and symptoms of adverse reactions relating to fluid retention, including weight gain and heart failure. Rosiglitazone should be discontinued if any deterioration in cardiac status occurs.
Medsafe and the Medicines Adverse Reactions Committee continue to monitor the safety of rosiglitazone. Further information one the use of rosiglitazone is available at: http://www.medsafe.govt.nz/Medicines/infoSearch.asp
References
- European Medicines Agency. 22 July 2010. European Medicines Agency update on ongoing risk-benefit review of Avandia, Avandamet and Avaglim. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/07/WC500094981.pdf
- US Food and Drug Administration. 22 February 2010. Avandia (rosiglitazone): Ongoing review of cardiovascular safety. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm201446.htm
- US Food and Drug Administration. July 13-14 2010. Rosiglitazone cardiovascular safety meta-analyses. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218495.pdf
