Federal advisory panel with reservations, recommends keeping Avandia on the Market

Jul 16 2010

The Washington Post: "Federal advisers delivered a mixed verdict Wednesday on the diabetes drug Avandia,with a significant number of experts voting to recommend that it be pulled from the market because of safety concerns but a majority urging to keep it available, perhaps with tough new restrictions and new warnings." Avandia "was once the world's most popular diabetes drugs but has become the focus of intense debate because of concerns that it increases the risk for heart attacks and strokes. FDA Commissioner Margaret A. Hamburg will make the final decision about Avandia's future. Hamburg has pledged to make drug safety a priority, and many observers are watching what the agency does about Avandia as a potentially key moment for the FDA under the Obama administration" (Stein, 7/15).

The Los Angeles Times: "Reflecting the difficulty of balancing potential risks and benefits for individual patients, 10 members of the 33-member panel voted to keep Avandia on the market under close supervision, seven voted to permit continued marketing but with stronger label warnings, and three favored the status quo. One member abstained. Twelve members voted to remove the drug from the market. Several panelists said they were persuaded to vote in favor of limiting or eliminating Avandia because another drug, Actos, works as well but has not shown as many side effects. The votes by a majority of the committee's members essentially affirmed a recommendation by a similar panel in 2007 that concluded Avandia could increase the risk of heart attacks but nonetheless should remain on the market. … Reliance on Avandia has dropped sharply in recent years as evidence began to accumulate linking it to increased risk of heart attack" (Zajac and Maugh, 7/15).

The Wall Street Journal: "Several panel members expressed conflicted feelings. Panel member David Oakes, a biostatistics professor at the University of Rochester, said his vote to keep Avandia on the market wasn't a 'vote of confidence,' but reflected concerns about the quality of the data in several Avandia studies linking it to heart attack risk. ... Former FDA Commissioner David Kessler said the Avandia controversy 'will chart the future direction of the agency on drug safety,' and result in more time and money spent by companies getting drugs approved, and 'more safety for the consumer.' Dr. Kessler noted the recall of the painkiller Vioxx in 2004, which was, like Avandia, linked to serious heart problems after it was on the market. 'Vioxx and Avandia together have shown the agency and industry that they need to address serious, but common adverse events' before approval" (Mundy and Corbett Dooren, 7/14).  

The Associate Press: "The agency convened the two-day panel meeting to help untangle over 1,000 pages of conflicting evidence about Avandia's risks. The drug has a long, knotty history at the FDA. Since diabetics are already predisposed to heart risks it is extremely difficult to tell which heart attacks are drug-related and which are simply caused by the disease. The task of evaluating Avandia's possible side effects across dozens of studies has dragged on for years without definitive answers" (Perrone, 7/15).