GlaxoSmithKline has had its wrists slapped by the US Food and Drug Administration over advertising for its heart disease drug, Coreg (carvedilol), which the latter deems to be “false or misleading”.
Specifically, the agency has reviewed marketing information the company presented at a congress last year, which it says omitted risk information and overstated the drug’s efficacy. In its warning letter – dated January 31 and posted on its website yesterday, the FDA said say that the information “raises serious public health and safety concerns because it fails to include any risk information about Coreg, which is associated with serious risks.” Moreover, it notes that it had previously objected, in letters dated October 15, 1997 and February 9, 1999, to Coreg journal advertisements that failed to adequately present risk information. “We are concerned that you are continuing to promote Coreg in a similarly violative manner,” it added.
Coreg, which is approved to treat mild to severe heart failure, ventricular problems after a heart attack, and hypertension, has been associated with problems, including heart attack in angina patients who abruptly discontinue therapy.