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The Food and Drug Administration says that some over-the-counter acne products can cause severe hypersensitivity or allergic reactions and is warning consumers to discontinue use immediately and seek emergency medical attention if they experience such symptoms.
The reactions seem to be on the upswing, according to the agency’s review of reports from 1969 to early 2013.
A hypersensitivity reaction could occur within minutes or up to a day after product application. The products of concern are under names such as “Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean Clear, and store brands,” the FDA reported. The products are available as “gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.”
The dangerous symptoms differ from the labeled side effects, which are: “redness, burning, dryness, itching, peeling, or slight swelling,” the news release reported.
The FDA cannot determine at this time if these hypersensitivity reactions are caused by the active ingredients benzoyl peroxide or salicylic acid or by other inactive ingredients. The FDA is planning to continue monitoring this issue and is working with manufactures to provide warning labels that alert consumers to the possibility of the dangerous reaction.
“Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don’t develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label,” the FDA reported.
Healthcare professional are urged to report adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Reports can be submitted at www.fda.gov/MedWatch/report.htm or forms can be requested at 1-800-332-1088.
Agencies/Canadajournal
