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Suspension of Avandia (rosiglitazone) from New Zealand market

Diabetes medicine rosiglitazone will be withdrawn from the New Zealand market on 29 April 2011 after a safety review found an elevated risk of cardiovascular events in patients treated with this medicine.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).

Media Release on 17 February 2011 from Ministry of Health

 



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