23, February 2010
By Kounteya Sinha & Pushpa Narayan
New Delhi/Chennai, India
The drug, used by millions of diabetics in India, was found by the US FDA to increase the risk of heart disease and death. The committee, being formed by DTAB, which met on November 9, will have as members the head of the department of pharmacology from AIIMS and NIPER, officials from the Indian Medical Association, Indian Council of Medical Research and director of the Indian Veterinary Research Institute.
Drug controller general of India Dr Surinder Singh said, “The US FDA is yet to take a decision on whether to ban the drug. Our committee will review latest data and decide what India should do.”
US FDA had first sounded an alert against Rosiglitazone’s possible side effects in 2007. A study published in the New England Journal of Medicine then found that Avandia (brand name for Rosiglitazone in US) puts users at a 60% greater risk of heart failure and a 29% greater risk of death than other medication. India’s National Pharmaco Vigilance Advisory Committee reviewed the data in January 2008 and in April, Dr Singh recommended all manufacturers of Rosiglitazone to carry a black box warning consumers and doctors about its risks.
After another study, FDA reviewers said there was strong evidence that Rosiglitazone conferred an increased risk of heart attack and heart failure. They also said GlaxoSmithKline did not do enough to warn patients of the drug’s potential risks. Avandia was once one of the biggest–selling drugs; with $3.2 billion worldwide sales in 2006.
According to Dr Anoop Misra, head of diabetes department, Fortis Hospitals, 65% of India’s 5 crore diabetics use oral drugs. Glitazones make up 15% of this share. “There has been a decline in use in urban India. But some rural or suburban doctors are still prescribing it,” Dr Misra said.
Medicine Under Lens
- A study claims diabetes drug Rosiglitazone puts users at a 60% greater risk of heart failure and a 29% greater risk of death
- India has now formed a 6–member panel of experts to decide whether the drug should be banned in the country