The U.S. Food and Drug Administration wants its most serious warning, a “black box,” printed on GlaxoSmithKline’s second-best selling drug, Avandia. The FDA made the request to GSK on May 23, and it informed the U.S. House of Representatives of the request at a June 6, 2007 hearing on Avandia’s potential health risks.

The black box would warn patients that Avandia increases the risks of congestive heart failure. Glaxo has not agreed to the request. The drug company makes $3 billion annually from Avandia sales.

The FDA has also asked for Avandia’s leading competitor, Actos, to carry a black box warning as well. The FDA has not issued an Avandia recall.

Concern in the House was that the FDA is not doing enough to protect consumers. The FDA is still investigating claims the drug causes heart attacks and chest pain. A similar warning or Avandia recall could follow. Nevertheless, some representatives are frustrated with the FDA’s apparent failure to take action.

“The FDA dropped the ball,” Rep. Henry Waxman, Democrat from California, said at the Congressional hearing.

Source: Sabine Vollmer, “FDA asks for stiff Avandia warning,” Raleigh News & Observer, June 7, 2007.