Last week, European Medicine Agency announced a ban on the use of rosiglitazone, a widely prescribed but controversial anti diabetes drug. In the US, the Food and Drug Administration decided to severely restrict the availability of the drug but stopped short of an outright ban. Marketing of the drug with the brand name, Avandia, belonging to GSK has been under a cloud from 2007 when the first serious objection to its safety surfaced. Avandia was approved by the US FDA in May 1999 for the treatment of type 2 diabetes and the drug is widely prescribed in the US, European and Asian markets. Doubts about the safety of Avandia came in the open with the publication of a study in New England Journal of Medicine in May 2007 by the US cardiologist, Dr Steven Nissen of the Cleveland Clinic. The study had pointed out 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 and held the view that Avandia was no riskier for the heart than other diabetes drugs. Although Dr Nissen's findings raised some concern amongst some patient groups, the US FDA chose not to take any serious steps to limit the use of the drug among patients except directing GSK to issue a black box warning on the label. Subsequently in November 2008 the US advocacy group, Public Citizen, called upon the US FDA to ban Avandia as it found to cause death from liver failure and poses many other life-threatening risks.

Again in last July, 12 out of a 33 member joint experts committee attached to the US FDA voted for the removal of the drug from the US market for its adverse drug reactions. As majority members of the panel did not openly support the withdrawal suggestion, the FDA did not resort to any action. The US FDA has a track record of extremely hesitant approach towards pulling out unsafe drugs from the market. This was what had happened in the case of Vioxx in 2004. The FDA did not ban the drug despite it killed several thousands of people. Merck withdrew the drug from markets on its own fearing multiple law suits from patient groups involving billions of dollars. The reason for the hesitation to withdraw unsafe drugs on the part of FDA is somewhat obvious. The drug is cleared for marketing by the FDA after the scrutiny of all reports of studies and human trials. Frequent withdrawal of drugs already allowed to be marketed would, therefore, put the integrity and competence of this prestigious regulatory body under a cloud. This is something what the US government has to look into. In India, rosiglitazone is already marketed by GSK, Sun Pharma, Dr Reddy's,Torrent, Ranbaxy and 30 others for some years. Safety of the drug has been under discussion here also and DTAB had already set up a six-member expert panel to review the safety of the drug. And as expected, it is taking time to come to a decision. Now, the EMA ban probably embolden the DCGI to order a withdrawal without any further delay. It is high time that the health ministry in the country acted on its own in matters like banning a harmful drug without waiting for a US FDA or EMA decision.