Rosiglitazone (Avandia/Avandamet) is a medicinal product which was authorised for use across the European Union through a European licensing process, as a second line treatment in the management of type II diabetes, for use only when other treatments had either failed, or were unsuitable for a patient.
Use of Avandia (rosiglitazone) was contraindicated in patients with heart failure or a history of heart failure since its first authorisation in July 2000. The combination of rosiglitazone with metformin, approved as Avandamet was also contraindicated in patients with heart failure or a history of heart failure. Following authorisation, use of these medicines was further restricted several times by the introduction of new warnings and contraindications on their use in patients with heart problems and this information was communicated to healthcare professionals.
In July 2010, the European Committee on Medicinal Products for Human Use (CHMP) initiated a further review to determine the impact of newly published data on the risk of cardiovascular problems and on the overall benefit-risk profile for rosiglitazone-containing medicines. These new data included two published studies examining rosiglitazone1,2 and newly available information from the US Food and Drug Administration which raised additional concerns regarding the cardiovascular risk with rosiglitazone compared with both placebo and pioglitazone.
The new studies involved a large number of diabetic patients and added to the accumulating evidence from different global data sources and different types of studies on rosiglitazone and cardiovascular risk.
In view of the restrictions already in place relating to use of rosiglitazone, the CHMP could not identify additional measures that would reduce the cardiovascular risk. It was therefore concluded that the benefits of rosglitazone no longer outweighed its risks and the CHMP recommended suspension of the marketing authorizations.
The IMB communicated the outcome of the EU review and its recommendations to healthcare professionals and the public on Thursday 23rd September 2010.
Advice provided to healthcare professionals and patients:
- Prescribers were advised not to issue any new or repeat prescriptions of rosiglitazone-containing medicines
- Prescribers were advised to review currently treated patients and switch them to suitable alternative treatment
- Pharmacists were advised to refer patients to their doctor for advice on their treatment
- Patients were advised to make an appointment to discuss their treatment and not to stop taking rosiglitazone without consulting their doctor
KEY MESSAGE:
European Regulators, including the IMB, have recommended that rosiglitazone be withdrawn from clinical use. As research has not identified any particular groups of patients for whom the benefits of rosiglitazone outweigh the risks, rosiglitazone will cease to be available in Europe within the next few months. In Ireland, a recall action to withdraw residual stock from the marketplace was initiated on Wednesday 20th October 2010. The IMB advised patients in September 2010 to consult their doctor about switching to a suitable alternative medicine.
References:
1-. Graham DJ et al. Risk of acute myocardial infarction, stroke, heart failure, and death in
elderly. Medicare patients treated with rosiglitazone or pioglitazone. JAMA doi:10.1001/jama.2010.920.
2-. Nissen SE et al. Rosiglitazone revisited. An updated meta analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med doi: 10.1001/archinternmed. 2010.207
Further information is available at www.imb.ie and www.ema.europa.eu
About Emmanuelle Pinjon
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