The FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. 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 should also stop using the product if they develop hives or itching.
These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels.
Based on the information reported, the FDA cannot determine if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid; the inactive ingredients; or by a combination of both. The hypersensitivity reactions may occur within minutes to a day or longer after product use.
The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.
“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, M.D., a medical officer at the FDA. “It’s important that consumers know about them, and that they know what to do if they occur.”
From 1969 through January 28, 2013, FDA received 131 reports from both consumers and manufacturers of allergic and hypersensitivity-related adverse reactions associated with these products. About 42% of these reactions occurred within minutes to 24 hours of use. The affected persons ranged in age from 11 to 78 years.
Forty percent of these reports described severe allergy symptoms such as throat tightness, shortness of breath, wheezing, low blood pressure, fainting, or collapse. Isolated instances of hives; itching of face or body (even of parts of the body where the person did not apply the medication); and swelling of eyes, face and lips were also reported. Consumers should avoid using an OTC topical acne product again if they have previously experienced a hypersensitivity reaction with its use. While no deaths have been reported, 44% of the cases required hospitalization.
Manufacturers of OTC topical acne drug products have the option to add label directions for sensitivity testing for new users of their products. The FDA encourages new users of OTC topical acne drug products to follow these directions. According to these directions, 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 three days. If no discomfort occurs, then the product can be used according to the directions on the Drug Facts label.
See the FDA Safety Communication