Times of India
08 October 2010
By Rupali Mukherjee
Mumbai, India

Med Enhances The Risk Of Heart Attack

India has finally decided to ban the widely prescribed diabetes pill, rosiglitazone (marketed as Avandia) with immediate effect. The decision to withdraw the drug from retail shelves was taken by a health ministry expert panel on Thursday. No fresh stocks can be imported or made in the country.

The pill, marketed by drug major GlaxoSmithKline as Avandia in many countries, has reported an increasing evidence of heart risk in studies across the world. While Europe has already pulled out the drug from the shelves last month, US regulators announced tight restrictions on its use.

Sources said that as a first step, sales of the medicine will be suspended till a final order for banning the drug is issued by the ministry over the next few weeks. Drug regulator Dr Surinder Singh was not available for comments.

The drug regulator, along with a panel of experts and doctors from pharmacology, endocrinology and medicine, recommended a ban on the drug as they felt Indians are at a heightened risk of early and frequent heart attacks, and diabetic patients are not always prescribed cardio–protective drugs that should be given to all patients with diabetes.

"So giving rosiglitazone to a diabetic may actually increase the risk manifold of getting heart problems," said a panel member.

Avandia (rosiglitazone) has been the subject of a raging debate for the last three years after one of the first studies in 2007 reported that it increased heart risk in diabetic patients. The studies compelled the US to issue a security alert.

Anoop Misra of Fortis Hospitals, Delhi, and part of the government committee: "Banning of rosiglitazone is more important for Indians, since they, as an ethnic group, are highly predisposed to early and severe clustering of cardiovascular risk factors (syndrome X) and heart attacks.

Indeed, any new drug for treatment of diabetes and hypertension should be rigorously tested in India for evaluation of safety for heart. Quick corrective measures of the DGCI, first stopping trial of Rosiglitazone in India (TIDE Trial) and then banning the drug, means that scores of lives in India, endangered by this drug, could be saved now".