Federal health officials are warning consumers who use anti-acne treatments about rare but potentially deadly allergic reactions that can cause swelling of the face and difficulty in breathing.
The Food and Drug Administration says the problems have been reported with gels, face washes, pads and other products that contain benzoyl peroxide or salicylic acid. But the agency says it’s unclear whether those ingredients or some combination of other substances trigger the reactions.
The over-the-counter treatments are sold as Proactiv, Neutrogena, MaxClarity, Oxy, Aveeno and other brands. For now the agency wants consumers to stop using the products immediately if they experience tightness of the throat, breathing problems, lightheadedness or swelling of the eyes, face or lips. Regulators say the problems are much more serious than rashes often seen with skin 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 FDA. “It’s important that consumers know about them and that they know what to do if they occur.”
From 1969 to 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.
Based on the information reported, FDA cannot determine if these reactions were triggered by the products’ active ingredients, the inactive ingredients or a combination of both.
While no deaths have been reported, 44% of the cases required hospitalization.
The FDA said new users of topical acne products should use a small amount on one or two affected areas of the skin for three days to test for sensitivity reactions.
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