The US Food and Drug Administration directed GlaxoSmithKline to place a black box caution on its diabetes drug ‘Avandia.’

According to USFDA, Avandia’s use could give rise to chest pain or coronary failure. More than two million people throughout the world take the drug to treat Type-II diabetes.

Generic versions of Avandia, its scientific name is rosiglitazone maleate - are available under 10 different brand names in the Indian market and sold to around eight million people.

GSK sells the drug under ‘Windia’ brand name in India.

A “black box” notice is the FDA’s hardest caution, which becomes compulsory when examinations point out that the drug contains a major risk of grave or life-threatening fallouts.

Worries regarding Avandia’s safety began when a study in ‘The New England Journal of Medicine’ in May described that patients who used Avandia experienced a 43% higher risk of heart failure and a 64% higher risk of dying of heart troubles.

The FDA’s Dr. Janet Woodcock said, “We are keeping Avandia in the market because we have concluded that there isn’t enough evidence to conclude the risk for heart attack or cardiac ischemia is higher than for other Type-II diabetes drugs.”

GSK will begin an examination equating Avandia to other medications to notice whether the heart risks are unique to it alone.

In India, no such warning on rosiglitazone has been released by the Drugs Controller General Dr. M. Venkateswarlu.

Rosiglitazone is popular in India as it regulates insulin and blood sugar and also have a favourable impact on lipids, coagulation and fat in liver.

Dr C.M. Gulati, drug specialist and editor of the Monthly Index of Medical Specialities said, “The mechanism for increased risk of death from heart attacks may be due to the adverse effect of rosiglitazone on lipids, particularly because of the increase in bad cholesterol by 18.6 per cent. The drug was claimed to ‘have a favourable effect on lipids’ when launched, which is a false claim.”