The FDA held a panel this week to decide on whether Avandia, a diabetes drug effective in lowering blood sugar levels, should be restricted or taken off the market entirely due to risks to heart health. The maker of Avandia, GlaxoSmithKlein, claims Avandia is safe and that evidence of the risks has been exaggerated pointing to its own RECORD study for support. However, many now say that the RECORD study was fundamentally flawed and would never have held water in the drug’s initial approval process. An FDA study indicates that seniors taking Avandia compared to seniors taking Actos (a comparable and competing drug) had significantly higher risks of heart attack, stroke, and fatality. 12 members of the panel voted to discontinue the distribution of Avandia, 10 voted that it should be distributed but its use curtailed with additional label warnings and possible sale restrictions, 7 voted for more label warnings alone, and 3 voted to continue sales with no changes. The FDA does not have to follow the recommendations of the panel and will reach a final decision in the near future.
