FDA panel votes to keep Avandia on market with more restrictions


ABC World News (7/14, story 5, 0:25, Sawyer) reported, “A surprise decision on Avandia [rosiglitazone]. Advisers to the Food and Drug Administration recommended keeping Avandia on the market,” although most “advisers did recommend stricter warning labels and the FDA will now decide which course to take.”
The New York Times (7/15, A1, Harris) reports on its front page that the 33 panelists “took six votes on a variety of issues” and when asked what the FDA should do, “12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.” Dr. Janet Woodcock, director of the FDA’s drug center, “said that the agency took the panel’s advice seriously and that it would consider its regulatory options.”