Doctors welcome decision to make Avandia available

Dubai: Physicians in the country heaved a sigh of relief following an announcement that popular diabetes drug Avandia will remain available, albeit with stronger warnings for increased heart risks, following a recommendation from the US drug authority.

A panel of external experts recommended to the US Food and Drug Administration (FDA) on Monday that Avandia, or rosiglitazone maleate, continue to be available with stronger warning.

FDA is not bound to follow the panel recommendations but adopts them frequently.

Journal report

The safety of the GlaxoSmithKline (GSK) drug was called into question in May with the publication of an analytical study in the New England Journal of Medicine, which contended that Avandia increased heart failure risks by 43 per cent.

Dr Abdul Razzak Al Madani, president of Emirates Diabetes Society, told Gulf News physicians should now be careful to explain the risks of the drug, used to treat Type II diabetes.

"There is not enough evidence of the risks compared to other drugs. But we have to explain to the patient and leave the decision to him," he said.

"If it's working fine and there are [no serious side effects], there is no good reason to discontinue it. Unless, of course, the patient requests it," he added.

He stressed that the drug safety scare highlighted the importance of preventing diabetes as "there are no medicines without side effects".

Dr V.J. Sebastian, head of cardiology at Welcare Hospital, told Gulf News he was relieved that the drug remained available although he would be prescribing it less.

"I'm happy because it is a very good drug for patients with insulin resistance," he said. "[But] we will now have to be very careful in selecting patients [to prescribe the drug] and carefully monitor them for heart failure and fluid retention," he added.

He said he used to prescribe Avandia to 40 per cent of his patients. Now, he plans to prescribe to about 30 per cent of patients.

The Health Ministry will not take immediate action on the FDA panel's recommendation of stronger warnings on Avandia.

'No immediate action'

Dr Fatima Ali Abdullah, deputy director of drug control at the ministry, told Gulf News they need time to peruse the recommendation and weigh the risks against the benefits.

In a press release, GSK stated they were happy with the advisory committee's decision.

"We welcome the decision as positive for patients. This was the first opportunity for these scientific experts to review the full data behind Avandia," said Dr Ronald Krall, the company's chief medical officer.

The UAE has the second highest rate of diabetes, according to the International Diabetes Federation.