FDA Warns Allergan Inc For Misrepresentation of True Aczone Results

On the 17th August 2009, the Division of Drug Marketing, Advertising and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) sent a warning letter to Mr E.I. Pyott Chairman and CEO of Allergan Inc, for false and misleading advertising of its Aczone (Dapsone) Gel 5% acne product.

The FDA informed Mr Pyott that the Journal Advertisement overstated the efficacy of Aczone and it omitted important risk information associated with its use. As a result it violates the Federal Food, Drug and Cosmetic Act.

Actual Results Shows Aczone Does not Work as Claimed

Allergen stated in their Journal Ad that Aczone works fast by reducing inflammatory lesions by 24% within 2 weeks. The FDA stated that this was a complete misrepresentation of the true results; which showed that patients using a placebo experienced a 22% inflammatory reduction within 2 weeks.

This insignificant 2% margin shows that Aczone is no better at reducing inflammatory lesions than using nothing at all.

Omission of Risk Information

The FDA also informed Mr Pyott, that Allergan Inc. had omitted the risk information in their Ad, that using Aczone Gel followed by benzoyl peroxide can cause a temporary yellow or orange discoloration of the skin and hair.

Immediate Action Demanded By the FDA

The DDMAC informed Allergan that this is a serious matter and they must immediately cease with their advertising and promotional materials that violate the FDA Drug And Cosmetic Act.

Allergan were also requested for an immediate reply to the FDA informing them of what actions have been taken to resolve this serious situation. And a comprehensive plan on how they shall inform the public of the true results. This they must comply to by the 28th August 2009.

The Rosacea Acne Times was able to obtain a copy of this 5 page warning fax sent from the FDA to Mr Pyott, that details the complete facts and the actual research study results.