Diabetic drug to go off shelves

Rosiglitazone has already been banned in Europe and United States

The existing stocks in medical shops, however, will not be withdrawn for the immediate benefits of patients. This was decided thinking that existing patients on this drug—sold under the brand name of Avandia, Avandaryl, Avandamet, and Avaglim—may not get adequate time to consult doctors to shift to an alternate treatment regimen, sources told Deccan Herald.

But once the stocks are exhausted, there will not be any fresh supply as the Drugs Controller General of India has instructed state drugs controllers to immediately suspend all licences given to pharmaceutical companies for manufacturer, sale and distribution of this drug.

The decision was taken on Thursday following the recommendation of an expert panel to look into the safety issues related to rosiglitazone in the wake of European Medicine Agency banning the drug and US Federal Drug Administration severely restricting its use.

The warning came globally in 2007 when a meta-analysis of controlled clinical trials found increases in the risk of myocardial infarction and a near-significant increased risk of death from cardiovascular causes when rosiglitazone was compared with placebo or with other diabetes drugs.

The Indian expert panel recommended immediate suspension of import as well as manufacturing of rosiglitazone and all its fixed dose combinations because its “continued use would lead to more cardiovascular events and adverse effects on lipid profile,” DCGI’s Surinder Singh said in a letter to state drugs controllers.