OTC Topical Acne Products
June 26, 2014
FDA issued a warning that salicylic acid or benzoyl peroxide containing over-the-counter topical acne products can cause rare, potentially life-threatening allergic reactions or serious irritation. These reactions may occur immediately or a day or more after exposure and are different than currently described local irritations present on the drug labels (eg, redness, itching, peeling, dryness, burning). It is unclear if the reactions are due to inactive ingredients, active ingredients, or combinations of the previous. Over-the-counter topical acne products are sold under various brand names (eg, Neutrogena, Oxy, Proactiv) and come in multiple formulations (eg, face washes, cleansing pads, lotions, gels, solutions). FDA is monitoring this issue and will work with manufacturers if label changes are needed.
Advise patients to stop using the product and seek immediate medical attention if signs of serious hypersensitivity reaction occur (eg, dyspnea, throat tightness, cardiovascular changes, hypotension, hives, mucosal changes, syncope, swelling of the lips, face, eyes, or tongue). When starting a new over-the-counter topical acne product it is recommended that a small application be placed daily for 3 days to ensure no hypersensitivity reaction or severe irritation occurs.
Patients should talk to their healthcare provider about symptoms of severe hypersensitivity reactions. Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
Additional information is available at the following links:
June 26, 2014; University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.