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Acne Medication May Cause Serious Skin Reactions

Filed June 26th, 2014 Eric

Popular forms of Acne medication may cause rare, but serious allergic reactions, the U.S. Food and Drug Administration (FDA) warns.

The FDA released a safety communication informing the public that certain over-the-counter (OTC) topical acne products can cause serious and even life-threatening allergic reactions. The agency said consumers should “stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.” Consumers are also advised to also stop using the product if they develop hives or itching. 

These serious hypersensitivity reactions vary from minor spots of redness to burning so severe it can lead to hospitalization. Skin irritation that may occur at the product application site includes redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels, the FDA said.

Many of the popular OTC topical acne products can cause these reactions, including Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear. Store brands can also cause the same irritation. These products can be purchased as lotions, gels, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

Based on the information it has received, the FDA said it is unable to determine if the serious hypersensitivity reactions were caused by the active ingredients in the acne products (benzoyl peroxide or salicylic acid), the inactive ingredients, or by a combination of both.  The FDA added that hypersensitivity reactions may occur within minutes to a day or longer after product use, depending on the person.

The agency is encouraging all manufacturers to add directions for advising sensitivity testing for new users of their products to all product labels. Doing so would reduce the risk of serious hypersensitivity reactions, the FDA said. The agency is also encouraging all new users of OTC topical acne drug products to follow these directions.

The directions state, “before using an OTC topical acne product for the first time, consumers should apply a small amount to one or two small affected areas of the skin for 3 days.  If no discomfort occurs, then the product can be used according to the directions on the Drug Facts label,” the FDA said. Consumers are also advised avoid using an OTC topical acne product again if they have experienced a hypersensitivity reaction with its use.

The agency said they are continuing to investigate and evaluate this safety issue, and will work with manufacturers regarding any future label changes that would address the risk of severe hypersensitivity reactions.

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