Diabetes drug to be withdrawn over heart risk fears

Dr Stewart Jessamine. File photo / Dean Purcell

A diabetes drug alleged to be a factor in 100,000 cases of heart failure is being withdrawn from the New Zealand market.

Rosiglitazone, which is sold in New Zealand under the name Avandia, was suspended from the European market last year after a US study implicated it in thousands of heart attacks, strokes and other heart failures.

The US Food and Drug Administration (FDA) kept it on the market with significant restrictions on its use.

Medsafe Group Manager Dr Stewart Jessamine said a safety review had found New Zealand patients taking the drug suffered an increased risk of cardiovascular events.

It will be withdrawn from the market on April 29 - a deadline that should give patients and doctors enough time to find alternative treatments, he said.

"The safety concern centres on the potential for rosiglitazone to cause unwanted effects on the heart.

"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.

"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."

Avandia is not publicly funded in New Zealand and it is estimated less than a hundred patients are taking it.

FDA scientist and lead author of a US study David Graham, asked for the drug to be banned when his study was released in September.

He said since Avandia was introduced in 1999, it may have been involved in 100,000 heart attacks, strokes and other heart failures.

Medsafe has been monitoring the safety of Avandia since 2005, together with the Medicines Adverse Reactions Committee and the New Zealand Pharmacovigilance Centre.

Dr Jessamine said the decision to finally withdraw the drug was prompted by its removal and restricted in other markets.

He advised doctors not to give any new patients the drug and to review the prescriptions of patients who are taking it.

"Doctors are requested not to initiate new patients onto treatment with Avandia and to review the treatment of any patients taking this medicine."

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 as Avandia, such as pioglitazone, a statement from the agency said.

GlaxoSmithKline PLC said in an earlier statement that rosiglitazone was an important treatment option for appropriate type 2 diabetes patients.

The company's European medical director Tony Hoos said the drug had been studied in more than 50,000 patients.

- NZHERALD STAFF