Nurses and other providers should be aware that the Food and Drug Administration (FDA) has issued a drug safety communication regarding the possibility of hypersensitivity reactions from over-the-counter (OTC) topical acne products that contain benzoyl peroxide or salicylic acid. The FDA's database of adverse events identified 131 cases of hypersensitivity reactions from 1969 to 2013; the majority were reported between 2012 and 2013. Almost half of those who experienced serious hypersensitivity reactions required hospitalization for their symptoms. The FDA is currently not able to determine whether the hypersensitivity reactions are related to one of the active ingredients, an inactive ingredient, or a combination of both. The hypersensitivity reactions differ from the irritation that can occur at the site of application; they include, according to the reports, throat tightness; difficulty breathing; swelling of the eyes, face, lips, or tongue; and feeling faint. The brands noted in the adverse event reports include Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean and Clear, and various store brands. The hypersensitivity reactions can occur as soon as immediately after use to as long as several days after use.

Nurses who recommend any of these OTC topical acne products should be sure to provide information about the possibility of hypersensitivity reactions, which, though rare, can be serious. When beginning use of a product, patients should be instructed to limit application to one or two areas for the first three days. As long as hypersensitivity reactions don't occur, the product can then be used freely according to the instructions. If swelling or hives occur the patient should discontinue the product and contact the prescriber. The product shouldn't be reintroduced after a hypersensitivity reaction because second and often more severe reactions were noted in the case reports reviewed by the FDA.

The FDA drug safety communication regarding the warning is available at http://1.usa.gov/1wExoyc.