The debate whether the diabetic drug, rosiglitazone, should be withdrawn from the global markets or not on account of its serious adverse drug reactions continues to drag on for the last 3 years as the US FDA has not been able to take a decision. 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. The concern 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 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 drugs. 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 in 2008. 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 a black box warning on the label. The US advocacy group, Public Citizen, then called upon the US FDA in November 2008 to ban Avandia as it found to cause death from liver failure and poses many other life-threatening risks.
Early this month, a joint experts committee of endocrinology, drug safety, and diabetes to advise the US FDA on Avandia also did not recommend to remove the drug from the US market. Although as many as 12 out of this 33 member committee voted for the removal of the drug from the market other members did not openly support the withdrawal suggestion. Now it is for the US FDA to decide what to do with the controversial drug. Meanwhile, it is reported that GSK agreed to pay as much as $460 million to settle approximately 10,000 suits alleging that the drug caused heart attacks. As a fall out of this controversy, several physicians in US have already switched from rosiglitazone to pioglitazone, a somewhat safer alternative. Despite the law suits and unfavorable reports about the safety of the drug GSK is extremely hesitant to withdraw Avandia from the markets on its own unlike Merck which withdrew its blockbuster, Vioxx, in 2004 under similar circumstances. As the US FDA had allowed Avandia to continue in the market, most countries including India are hesitant to ban the drug. Rosiglitazone is sold in India by GSK under its brand name Windia and generic versions are sold by Sun Pharma, Dr Reddy's Labs, Torrent Pharmaceuticals and Ranbaxy among 30 other firms. Drug Technical Advisory Board had already set up a six-member expert panel to review the safety of the drug in the country. A decision to allow continuation of marketing the drug in the country is usually taken after submission of the report by the panel. While it is important that a proper procedure has to be followed before any serious action such as banning a drug is taken, the authorities have to realize that any delay in prohibiting an unsafe drug is endangering lives of millions of poor patients in the country.