FDA warns Allergan on Aczone promotion

Washington — An advertisement for Aczone (Allergan), a gel used to treat mild-to-moderate acne, “grossly overstates” the drug’s effectiveness, the Food and Drug Administration (FDA) stated in a letter released Aug. 21.

The FDA said the medical journal ad left out important information about risks, and was misleading in that it suggests that Aczone is safer than has been demonstrated, Reuters reports.

The ad claimed the medicine was shown to reduce inflammatory lesions by 24 percent in two weeks, but the FDA says studies show it only has a slight benefit when compared to placebo, according to Dow Jones Newswires.

An Allergan spokeswoman said the ad ran in March, April and May, but is no longer in use, and a new ad that addresses the FDA’s concerns began running in May, Reuters reports.