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news.The FDA's Division of Drug Marketing, Advertising, and Communications has requested that GlaxoSmithKline pull its adverts for heart drug Coreg, after finding the advertising to be misleading regarding the drug's efficacy and safety profiles.
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The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed advertising information for Coreg (carvedilol) tablets and found it to be false or misleading, as it omits material risk information and overstates the efficacy of the drug.
In a letter, the Division’s director, Thomas Abrams, stated that a poster advertising Coreg “raises serious public health and safety concerns because it fails to include any risk information about Coreg, which is associated with serious risks.”
The letter also pointed out that the DDMAC had objected in the past to journal advertisements for Coreg containing inadequate risk information. Abrams expressed a concern that GSK was “continuing to promote Coreg in a similarly violative manner.”
According to the product’s label, Coreg is indicated for congestive heart failure, left ventricular dysfunction following heart attack and hypertension. The product is contraindicated in a number of patient groups, including those with bronchial asthma, sick sinus syndrome, cardiogenic shock or those with decompensated heart failure requiring intravenous inotropic therapy.
In stating the product’s benefits, the DDMAC says, the poster fails to include risk information key to using Coreg appropriately, and instead, advises the reader to seek a separate source for this information.
The poster also overstates the product’s efficacy, the DDMAC found, suggesting that Coreg has shown cardioprotective benefits in hypertension, when the product has, in fact, not been tested specifically in hypertensive patients.
Furthermore, the presentation of the relative risk reductions in several trials has been deemed misleading because it does not reveal the absolute effect on these events, for example when compared to results for placebo.
The DDMAC has asked GSK to submit a written response to its letter on or before February 14. The company has been asked not only to put in writing how it plans to discontinue such promotional materials but to include a plan of action to circulate “truthful, non-misleading, and complete information to the audience(s) that received the violative promotional materials.”