U.S. health advisers voted to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the biggest drug controversies in recent years. FDA will now take the vote into consideration for a final decision on how the pill also known by the generic name rosiglitazone can be used.
Researchers at the Duke Clinical Research Institute (DCRI) reported after carrying out a re-analysis of data from a pivotal study RECORD that there is not a higher risk of heart attack and cardiovascular events in patients who take controversial drug Avandia.
The DCRI researchers re-assessed the original findings of RECORD, a study that drew criticism from an 2010 FDA advisory panel. The FDA advisory panel has now recommended loosening the restrictions on Avandia. |