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FDA Panel Votes To Modify Glaxosmithkline Plc's Avandia Restrictions-Reuters


Thursday, 6 Jun 2013 04:17pm EDT 

Reuters reported that U.S. health advisers voted on June 06, 2013 to recommend modifying market restrictions on GlaxoSmithKline's diabetes drug Avandia. 13 members of the advisory panel of outside experts favored modification, while seven others voted to remove the restrictions altogether and five panel members favored keeping current safeguards in place without changes. One committee member voted to withdraw Avandia from the market altogether. The U.S. Food and Drug Administration will take the vote into consideration for its final decision on how the drug can be used. Technical problems forced the panel to recast their votes twice, including once via paper ballot, but the results were unchanged. After two days of discussion, several panel members concluded that a reevalution of Glaxo's safety data for Avandia had allayed their concerns about whether the drug posed risks for death and disability from cardiovascular problems. As a result, several experts said they hoped to amend restrictions to include a new collection of data on the drug's safety and efficacy including the possibility of a new clinical trial or establishment of a registry.