Rosiglitazone (Avandia) and rosiglitazone with metformin (Avandamet): streamlined authority removed
Published in NPS RADAR
Date published: About this date
To highlight continuing concerns about the safety of rosiglitazone, from 1 July 2011 all PBS listings of rosiglitazone (Avandia) and rosiglitazone with metformin (Avandamet) will no longer be streamlined.1 Instead the listings will revert to conventional Authority status, and prescribers will be required to telephone Medicare for approval of any new or repeat prescription.
Rosiglitazone is a third-line choice. It may be considered as part of dual therapy when either metformin or a sulfonylurea is contraindicated or not tolerated. Insulin, exenatide, pioglitazone or a gliptin should also be considered instead of rosiglitazone in these scenarios.
Rosiglitazone is not indicated in combination with insulin or for triple oral therapy.
Do not use rosiglitazone in people with heart failure. Rosiglitazone may increase the risk of myocardial infarction, fractures and macular oedema.2–9 Avoid using rosiglitazone in people with ischaemic heart disease and take particular care when prescribing it to people with a high risk of cardiovascular events.
- Pharmaceutical Benefits Advisory Committee. Positive Recommendations made by the PBAC — March 2011. Canberra: Australian Government Department of Health and Ageing, 2011. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-mar11-positive (accessed 26 May 2011).
- Cobitz A, Zambanini A, Sowell M, et al. A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14,237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazone. Pharmacoepidemiol Drug Saf 2008;17:769–81. [PubMed]
- Mele J. Statistical Review and Evaluation — Avandia (rosiglitazone), 2007. http://www.fda.gov/ohrms/dockets/AC/07/briefing/2007-4308b1-02-fda-backgrounder.pdf (accessed 31 May 2011).
- Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007;356:2457–71. [PubMed]
- Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA 2007;298:1189–95. [PubMed]
- GlaxoSmithKline Australia Pty Ltd. Avandia product information. 14 August 2008. Australia.
- European Medicines Agency. Press release: European Medicines Agency: Committee for Medicinal Products for Human Use, 11–14 December 2005. 15 December 2005. http://www.emea.europa.eu/pdfs/human/press/pr/42148405en.pdf (accessed 31 October 2007).
- Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006;355:2427–43. [PubMed]
- Schwartz AV, Sellmeyer DE, Vittinghoff E, et al. Thiazolidinedione use and bone loss in older diabetic adults. J Clin Endocrinol Metab 2006;91:3349–87. [PubMed]