Tamil Nadu - Chennai

‘Rosiglitazone’ removed from diabetes drugs

CHENNAI: The debate over the use of controversial anti-diabetes drug ‘rosiglitazone,’ associated with heart attacks, congestive heart failure and bone fractures, is finally settled after a revision of international guidelines threw the drug out.

The American Diabetes Association and European Association for the Study of Diabetes (EASD) have removed the drug from the list of recommended second line drugs, following reports since mid last year of increased risk of heart attacks in patients using rosiglitazone.

Diabetologists in the State have hurried to welcome this move, one they say is “belated, but certainly a right step.”

The amendment issued by the ADA and EASD has a direct impact on more than 28 million people suffering from Type 2 diabetes and change the way it is treated.

While the first line of treatment involves giving oral doses of the drug metformin, second line treatment is where rosigliptazone was being used prior to a patient being put on insulin. In 2007, it was estimated that about seven to 10 million diabetics in India use the drug.

There are other safer alternatives available in the second line drugs band that do not have similar side effects, A. Ramachandran of Dr. A. Ramachandran’s Diabetes Centre, says.

“Prescriptions of rosigliptazone started coming down ever since the issue of unsafe side-effects was raised. At any rate, because of its known side effect of congestive heart failure, it was not being prescribed to obese people,” he adds.

When safer drugs are available in the same band, it would be wiser to recommend them instead of rosigliptazone.

Controversy about the drug was raised in June last year when the New England Journal of Medicine linked it to a 43 per cent higher chance of heart attack.

Anoop Misra, chief scientific advisor, Diabetes Foundation of India, said the same journal carried an editorial that warned the findings could not be taken lightly.

This was followed up by several other studies conducted by other organisations and pharma companies, revealing the same set of risks, Dr. Misra added.

While blister packs of rosigliptazone warned of ‘congestive heart failure’ the manifold increase of myocardial infarctions (heart attacks) was not attended to.

The US Food and Drug Administration, while not resorting to the ban, urged all manufacturers to print a warning on the label of all formulations containing rosiglitazone to caution heart patients.

The Drug Controller General of India also followed suit.

The Indian Pharmacovigilance Committee was also tasked to enquire into the safety aspect of the drugs.

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