The drug control authorities in India have clarified that there is no immediate plan to ban the controversial anti-diabetic drug rosiglitazone in India in the wake of recent observations by the US FDA. Senior health ministry officials said that the ministry will wait for the decision of the DTAB in this regard before taking any action.
Reacting to the recent controversies about the drug in the US, health ministry sources said that the review was still going on and there were no fresh information. “No new conclusions or recommendations about the use of rosiglitazone in the treatment of type-2 diabetes have been made yet,” sources said.
Rosiglitazone is sold by GlaxoSmithKline Pharmaceuticals Ltd and generic versions are made by Sun Pharmaceuticals Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other firms. GlaxoSmithKline sells the drug as Avandia overseas and Windia here.
On the basis of reports in 2007 that rosiglitazone increases risk of heart attack, the matter was examined by National Pharmacovigilance Advisory Committee (NPAC) in January, 2008 which recommended incorporation of “box warning” in the package inserted and other promotional literature of formulations containing rosiglitazone. Accordingly all State Drug Controllers were requested to direct manufacturers of rosiglitazone formulation to incorporate the box warning about cardiac risk.
“In January, 2010 it was reported that one US FDA report concluded that rosiglitazone should be removed from the market. US FDA in their website has posted information on safety review of rosiglitazone on February 23, 2010, which mentions that FDA’s review is ongoing,” a health ministry official clarified.
Meanwhile, DTAB had set up a six-member expert panel to review whether this diabetic drug needs to be banned from being sold in the country. An action will be taken only on report of the panel and the decision of the DTAB, it is learnt. The committee consists of a few officials from the Indian Medical Association, Indian Council of Medical Research and the Indian Veterinary Research Institute.
The rosiglitazone issue began in 2007, when a meta-analysis of data from 42 clinical trials -- led by Steven Nissen, of the Cleveland Clinic -- found a 43 per cent increase in relative risk of myocardial infarction among type 2 diabetes treated with the drug. The recommendations as part of the report from the Senate Finance Committee recently again revived the controversy.