Avandia Marketing Criticized by FDA

Stepping up its monitoring of drug advertising at medical conferences, the FDA last month sent a letter to GlaxoSmithKline PLC, ordering the company to ensure that sales representatives properly explained the side effects associated with the diabetes treatment Avandia, the Wall Street Journal reports. According to the FDA, Glaxo sales representatives at an American Association of Clinical Endocrinologists were heard "deny[ing] the existence of serious side effects" associated with the drug. Although Avandia's label was changed to include new cardiac safety concerns, two Glaxo representatives were heard saying that the label of Avandia had not been changed. In the letter, the FDA wrote, "These statements are clearly inconsistent with Avandia's labeling change. Indeed, not only did your representatives fail to disclose the important new risks ... they actually denied that any changes to the Avandia (label) had occurred and stated that they were not aware of any new risks." The FDA ordered Glaxo to write to any physician who may have heard the statement and clarify Avandia's side effect profile. In a separate letter, the FDA ordered Glaxo to pull a "misleading" Avandia ad that omits some of the drug's side effects and presents other safety concerns "in a confusing manner." Since 1999, the FDA has cited Glaxo five times for "improper, misleading, or false marketing." Glaxo spokesperson Karen Collins said that the company is "working closely with the FDA" and has "taken the appropriate corrective steps" (Adams, Wall Street Journal, 8/2).