The US advocacy group, Public Citizen, had called upon the US FDA last month to ban Avandia, the anti diabetic drug marketed by GSK as it found to cause death from liver failure and poses many other life-threatening risks. The advocacy group had identified 14 cases of Avandia-induced liver failure, including 12 deaths from the US FDA's Adverse Event Reporting System. According to Public Citizen, the drug increases the risk of heart attack by about 40 per cent, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluid accumulation in the eye. Avandia was approved by the US FDA in May 1999 for the treatment of type 2 diabetes and the drug is a widely prescribed blockbuster in the US and European markets. The concern about the safety of Avandia was first raised with the publication of a study in New England Journal of Medicine in May, 2007 by a prominent US cardiologist, Dr Steven Nissen of the Cleveland Clinic. The study suggested that the patients who are taking the drug have 43 per cent higher chances of suffering a heart attack. GSK had strongly disagreed with the findings of Dr Nissen at that time and held the view that Avandia was no riskier for the heart than other diabetes medications. However, the use of Avandia declined sharply in the US since then. The number of people taking Avandia dropped from a peak of 13.2 million in 2006 to 4.6 million for the last full year. This is despite the fact that the US FDA had not taken any serious step to limit the use of the drug among patients except directing GSK to issue black box warning the label. Now after the appeal made by Public Citizen for the ban of the drug, the American Diabetes Association and the European Association for the Study of Diabetes have also advised against the use of the drug.

In India, the Drug Controller General of India had placed rosiglitazone, under the scanner of national pharmacovigilance programme in August, 2007 in the wake of US FDA warning against the use of the drug. But, nothing has come out of that as yet. Rosiglitazone is sold by GSK under its brand name Windia in India and generic versions are sold by Sun Pharma, Dr Reddy's Labs, Torrent Pharmaceuticals and Ranbaxy among 30 other firms. The DCGI early last month asked companies selling rosiglitazone formulations to carry a warning on their labels cautioning against its potential risk to heart patients after the outcry by the Public Citizen. There has been a steady rise in post marketing complications of newly approved drugs especially during the last five to six years in the US and other major markets. That is forcing regulatory authorities to pull out more and more approved drugs from the market. A most recent case is that of rimonabant, an anti obesity drug. Rimonabant has been withdrawn from Indian and European markets just last month causing for serious side effects. This trend shows that there is something seriously wrong with the whole system of new drug approval by world's top regulatory bodies including in India. The situation is quite scary as several lakhs of patients are taking these newly approved drugs for cure but end up as fatally injured or dead.