Acne treatments that contain benzoyl peroxide or salicylic acid can trigger dangerous allergic reactions in some people, the U.S. Food and Drug Administration (FDA) warned on Thursday, June 26.
The FDA issued the warning about certain over-the-counter acne treatment products that are applied to the skin. They include products marketed under brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear, as well as many store-brand and generic products. All of the products are applied topically; they come in several different forms including gels, lotions, face washes, solutions, cleansing pads, toners, and face scrubs.
FDA received a total of 131 reports of allergic and hypersensitivity-related adverse reactions during the 44-year period from 1969 through January 28, 2013 – a little less than three per year. Reactions occurred in children as young as 11 years and adults as old as 78 years. More than four out of ten reactions happened within one day of using the 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.”
The allergic reactions differ from common side effects of the medications, which include burning, dryness, itching, peeling, redness, and slight swelling of the skin. Severe allergy symptoms included throat tightness, shortness of breath, wheezing, low blood pressure, fainting, and even collapse. Other people developed less severe symptoms, including 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. Nearly half of the people affected were hospitalized, although no deaths have been reported.
“FDA will continue to monitor closely and evaluate this safety issue,” Khurana says. The agency is also encouraging manufacturers to use the drug label to advise consumers how to test the product’s safety before using it for the first time.
For example, Khurana suggests that new users should apply a small amount of the product to a small affected area for three days. If no discomfort occurs, they can follow the labeled directions for normal use.
To find out whether you’re using one of the affected products, look for the words “benzoyl peroxide” or “salicylic acid” at the Active Ingredients section of the Drug Facts label on the package.
- Don’t use any of these products if you’ve had a bad reaction in the past
- Stop using the product if you develop itchiness or hives on the face or body
- Stop using the product and call for emergency medical services if your eyes, face, lips, or tongue begin to swell, your throat begins to feel tight, you feel faint, or you have difficulty breathing
If you do experience an adverse reaction, report it to FDA MedWatch online or by telephone (1-800-332-1088), fax (1-800-FDA-0178). If you prefer to use regular mail: Use FDA Form 3500B and mail to: MedWatch, 5600 Fishers Lane, Rockville, MD 20857.