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Medsafe Looking Into Avandia Safety

Fuseworks Media
Fuseworks Media
Medsafe Looking Into Avandia Safety

New Zealand medical authorities will investigate the New Zealand use of a diabetes drug, Avandia, alleged to be implicated in 100,000 cases of heart failure.

European officials have suspended the licence for rosiglitazone, the active ingredient of the drug, but the United States Food and Drug Administration (FDA) has kept the drug on the market, with restrictions on access. FDA scientist and lead author of a US study David Graham, has asked for the pill to be banned and has said since Avandia was introduced in 1999, it may have been involved in 100,000 heart attacks, strokes, deaths other heart failures.

New Zealand regulator, Medsafe, today said it was aware of and would review both the European Union and the US decisions to determine how they might affect the use of rosiglitazone in New Zealand.

"In the meantime, physicians are reminded to strictly adhere with the prescribing instructions for this medicine," a spokeswoman told NZPA.

Medsafe, in conjunction with the Medicines Adverse Reactions Committee and the New Zealand Pharmacovigilance Centre, had been closely monitoring the safety of rosiglitazone for several years, with the last review in March 2010. The committee recommended that Medsafe report back to the committee with the outcome of the FDA review, and include New Zealand usage data.

"People with type 2 diabetes have higher risks of suffering adverse cardiac outcomes compared to the non-diabetic population," the spokeswoman said.

Other medicines used to treat type 2 diabetes also had risks associated with their use.

"Patients who are taking rosiglitazone and who are concerned about the safety of their medication should contact their doctor," she said.

GlaxoSmithKline PLC has said that rosiglitazone is 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.


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