In a congressional hearing on June 13, 2007, the Food and Drug Administration (FDA) revealed that it has called for a black box warning, the sternest possible, on both Actos and Avandia.
More than a year ago, an FDA drug-safety supervisor recommended that Avandia carry that very warning and was promptly reprimanded for her pains.
After Dr. Nissen’s controversial article appeared last month in the New England Journal of Medicine, however, it took the FDA only two days to call for the black box upgrade regarding heart risk.
Throughout the hearing, which was chaired by Democratic Representative Henry Waxman of California, the Democrats criticized the FDA for being lax and the Republicans criticized Dr. Nissen for being inflammatory. Following the contentious meeting, a senior official at GlaxoSmithKline said that the whole issue has been blown out of proportion just so that Democrats can find fault with President Bush’s FDA.
During the hearing, a representative of GlaxoSmithKline testified that interim results from the lengthy RECORD trial are reassuring, finding no significant difference in cardiovascular death and heart attack between Avandia takers and control groups.
Apparently both Avandia and Actos are discussing the new warnings with the FDA, in a process that the companies say is supposed to take weeks to months. Since the Nissen report came out last month, Avandia prescriptions have fallen by twenty percent.
Sources: International Herald Tribune
The Wall Street Journal
See “The Latest About Avandia and Actos”, August 2007.