FDA Warns of Rare But Serious Reactions to OTC Acne Products

FDA says certain OTC acne products may produce severe hypersensitivity reactions such as throat tightness and difficulty breathing among others

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) People with acne have many choices of over-the-counter (OTC) products to help them clear their skin. The FDA is warning that some of these products may cause rare but serious and possibly life-threatening reactions.

The US Food and Drug Administration (FDA) is recommending consumers to stop using topical acne products and seek emergency medical care immediately if they experience severe allergic reactions or irritation.

Such severe reactions might include throat tightness, trouble breathing, feeling faint, or swelling of the eyes, face, lips or tongue. The FDA also recommends that consumers stop using their acne product if they develop itching or hives.

The OTC acne products that may cause these serious reactions include Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and various store brands.

"Seek medical care immediately if you have a severe reaction to an acne product."

The FDA was clear to point out that these severe reactions, or hypersensitivity reactions, are different than the local skin irritations that happen in the exact spot where the product is applied. These local reactions, which can include redness, burning, dryness, itching, peeling or slight swelling, are already a part of the Drug Facts label on certain acne products.

According to the FDA, it's not clear if the serious hypersensitivity reactions resulted from the acne products' active ingredients (benzoyl peroxide or salicylic acid), their inactive ingredients, or some combination of both.

The FDA is encouraging all of the companies that manufacture these acne products to add sensitivity testing directions to the product labels. These directions advise consumers who are about to use an OTC acne product for the first time to apply only a small amount of the product to one or two affected areas for three days. If these new users have no reactions or discomfort, then they may continue using the product according to the directions on its Drug Facts label.

Review Date: 
June 25, 2014
Last Updated:
June 26, 2014