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Drug ordered off the shelf

DUBAI — The UAE Ministry of Health has temporarily suspended the use of popular diabetes drug Avandia and has ordered it off the shelves within four weeks following concerns over its safety.

In a circular issued to all public and private pharmacies and health centres on Sunday, the ministry has asked all medical practitioners to stop prescribing the drug and offer alternatives to patients with Type 2 diabetes.

Diabetes is a major health issue in the UAE with 19 to 25 per cent of UAE nationals or one in four people being diabetic.

The decision was taken after a meeting with the manufacturer GlaxoKlineSmithe (GSK) on Sunday.

“The decision has been made following the US Food and Drug’s Authority’s limitation of the use of the medicine indicating that prolonged use could cause stroke and heart problems,” said Dr Amin Al Amiri, CEO of Medical Practice at the ministry.

“The decision is in the interest of the public and is the implementation of the recommendations from European and American drug control bodies to regulate medicines containing Rosiglitazone,” said Dr Amiri.

The Saudi Food and Drug Authority has already banned the drug.

Medical Director of GSK, DR Aly Ziwar confirmed that the drug had been ordered off the shelves. “We have been asked to stop import and distribution of the drug,” he said.

“However, it is important for patients to know that they should not stop treatment and should ask their physicians to prescribe an alternative,” said Dr Ziwar. He said the company was yet to estimate the amount of drug that would be withdrawn from the market.

The ministry has also asked patients to report any side effects caused by the medication.

In the UAE, the drug has been registered under the brand name Avandia, Avandamet and Avandaryl.

Dr Ziwar said GSK would continue with the ongoing clinical trial programmes for its investigational diabetes compounds in both Type 1 and Type 2 diabetes. “GSK has two assets in late stage development (Phase III) for diabetes including Syncria for Type 2 diabetes and otelixumab for Type 1 diabetes,” he said.

The drug has been under international scrutiny since 2007.

asmaalizain@khaleejtimes.com