Avandia Drug Trials in India Stopped by Indian Government

Here’s one more problem for Avandia, will it survive? BD

CBS News has learned that the Indian government has ordered Glaxo Smith Kline to suspend 19 drug trials in India for the controversial diabetes drug Avandia because of recently released studies showing potential heart problems with the drug. The trial continues at over 300 locations worldwide.

A spokesperson for Glaxo Smith Kline (GSK) told CBS News: "The DCGI (Drug Controller General of India) has written to Quintiles, the clinical research organization (CRO) running this trial in India, requesting that it be placed on hold with immediate effect.

Accordingly, all sites in India participating on the TIDE study were informed of the hold status by letter on Wednesday 30th June 2010. The reason stated by the DCGI was recent publication of a cohort observational study and a meta analysis concerning rosiglitazone. GSK, the principal investigators of TIDE and the CRO involved will provide the DCGI with any further data or information it requires in advance of a final decision on this study being made."