Ever since FDA has approved the TIDE trial in 2007, Avandia has been linked to an increased risk of heart attacks. Now with the regulator mulling to halt the trail, there is also a possibility of asking GSK to stop selling the drug in the US market.
Reportedly, FDA has called in the government scientific panel Institute of Medicine to review the ethics of such head-to-head studies. Joshua Sharfstein, principal deputy of Margaret Hamburg, commissionner of FDA, has asked the Institute of Medicine to complete its review before a July meeting to discuss Avandia that will involve outside advisers to the FDA.
In March 2010, Saudi Arabia’s FDA, saying that the potential heart risks of the drug outweigh its benefits, is said to have been suspended Avandia for six months.
However, Hertzel Gerstein, principal investigator of the trial, said: “This is an ethical and appropriate study to do.”
GSK also said that the scientific evidence did not prove that Avandia increased heart attack risks and it would welcome further scientific information that could help guide decisions around clinical trials and ultimately patient safety, reported the website.