Diabetes medicine rosiglitazone will be withdrawn from the New Zealand market on 29 April 2011 after a safety review found an elevated risk of cardiovascular events in patients treated with this medicine.
Medsafe Group Manager Dr Stewart Jessamine said one medicine containing rosiglitazone is currently marketed in New Zealand – Avandia. This medicine is not publicly funded in New Zealand, and it is estimated that less than a hundred patients are taking it.
“Patients who are taking Avandia are advised to make an appointment to see their doctor to discuss alternative treatments as soon as possible. Do not stop taking this medicine unless you have been advised by your doctor,” Dr Jessamine stressed. "Doctors are requested not to initiate new patients onto treatment with Avandia and to review the treatment of any patients taking this medicine."
“The withdrawal of this medicine from the market will not take place until 29 April 2011 to allow time for the safe transfer of patients to alternative treatments,” Dr Jessamine explained.
"Pharmacists who receive enquiries from their patients taking Avandia are encouraged to advise them to keep taking their medicine and direct them to seek advice from their doctor."
Medsafe, together with the Medicines Adverse Reactions Committee and the New Zealand Pharmacovigilance Centre, have been monitoring the safety of rosiglitazone since 2005.
MARC, which advises the Minister on medicines safety issues, undertook a risk-benefit review of medicines containing rosiglitazone after the European Medicines Agency suspended these medicines and the US Food and Drug Administration imposed significant restrictions on their use in September 2010.
“The safety concern centres on the potential for rosiglitazone to cause unwanted effects on the heart,” according to Dr Jessamine.
“However, it is important to note that people with Type 2 diabetes have higher risks of suffering adverse cardiac outcomes compared to the non-diabetic population. Untreated diabetes can also result in serious health outcomes.”
Medsafe has informed GlaxoSmithKline (NZ) Ltd of its decision to suspend consent to distribute Avandia. This action does not apply to other medicines in the same class (for example, pioglitazone).
Questions and Answers
1. What is rosiglitazone?
Rosiglitazone is a medicine used in the treatment of type 2 diabetes. It is available under the brand name Avandia.
Rosiglitazone belongs to the class "thiazolidinediones" (also called glitazones). These medicines work (through PPAR receptors) in fat, muscles and the liver to make the body more sensitive to insulin. This reduces the amount of glucose (sugar) in the blood.
2. Why did Medsafe and the Medicines Adverse Reactions Committee (MARC) review the benefits and risks of rosiglitazone treatment?
The benefits and risks of rosiglitazone-containing medicines were reviewed following the announcement of international regulatory action.
In September 2010, the European Medicines Agency announced that rosiglitazone-containing medicines were being suspended until the company could supply convincing data to identify a patient population in which the clinical benefits of rosiglitazone-containing medicines clearly outweigh the risks. At the same time, the US Food and Drug Administration announced significant restrictions on the use of rosiglitazone-containing medicines.
3. What data were reviewed by Medsafe and the MARC?
Medsafe and the MARC reviewed the results of meta-analyses, observational studies and randomised controlled trials (including the RECORD study). Much of these data are published on the FDA website; an overview is provided by Medsafe with the MARC meeting minutes at http://www.medsafe.govt.nz/profs/adverse.asp.
4. Why has the MARC recommended suspension of rosiglitazone-containing medicines?
The MARC considered that there is enough evidence that rosiglitazone increases the risk of heart attacks (myocardial infarction), which means that the risks of taking rosiglitazone outweigh the benefits. The same risk does not apply to patients taking pioglitazone.
In view of the restrictions already in place on the use of rosiglitazone, the MARC did not consider that further restrictions would reduce the risk of adverse effects on the heart. The MARC therefore recommended to the Minister of Health that rosiglitazone-containing medicines should be suspended until such time as satisfactory evidence can be provided by the company to identify a population of patients for whom the benefits of rosiglitazone treatment outweigh the risks.
5. What should patients do if they are currently taking Avandia?
Patients should NOT stop taking Avandia, but should make an appointment to talk to their doctor about alternative treatments.
The suspension will not come into effect until 29 April 2011 to allow patients time to change treatment.