GSK Gets Warning Letter for Misleading Coreg Promotional Aid

GlaxoSmithKline (GSK) was recently hit with an FDA warning letter for presenting a misleading promotional panel for its cardiovascular drug Coreg at an industry conference last June.

Issued by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), the warning letter focused on a Coreg (carvedilol) promotional aid that, according to the FDA, overstated the drug's efficacy. The promotional display was used as a stand-alone panel at the American Society of Health-System Pharmacists conference held June 19-23, 2004.

"While the panel shows a 23 percent relative reduction in mortality in the CAPRICORN trial, the [product labeling] states that the actual rates were 15 percent in the placebo group and 12 percent in the carvedilol group, a reduction in absolute terms of 3 percent," DDMAC stated in the letter, which was posted on the FDA's website. The CAPRICORN trial was one of several studies GSK used to gain approval for Coreg.

The product label data was included on the panel, but the agency said the "inclusion of this important contextual information only in very small type size at the bottom of the panel does not correct the misleading suggestion that Coreg achieved a much greater reduction in mortality than was demonstrated."

In addition to overstating Coreg's effectiveness, GSK didn't provide adequate risk information for the drug, DDMAC said. To make matters worse, GSK didn't have Coreg's product labeling readily available at its exhibit booth for conference attendees to pick up, the agency said.