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- Publication:2013/6/9
It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory panel recommended the FDA keep Avandia on the market and ease restrictions on its use. Now the FDA says it will carefully evalute and decide how to act.
Thirteen members of the advisory panel supported modification, Reuters reports, while 7 panelists voted to remove all restrictions. Five others recommended keeping the restrictions on the drug as-is. One voted to withdraw Avandia from the market completely.
"We appreciate the committee's thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendation of the committee," Dr. James Shannon, GSK's chief medical officer, said in a statement. "We continue to believe that Avandia is a safe and effective treatment option for Type 2 diabetes when used for the appropriate patient and in accordance with labelling."