Severe Allergic Reactions to Acne Treatments

On June 25, the Food and Drug Administration (FDA) issued a safety alert for consumers warning that over-the-counter (OTC) acne treatments containing benzoyl peroxide or salicylic acid (see table on this page for examples of product brand names) can cause rare but serious and potentially life-threatening allergic reactions.[1]

Examples of Over-the-Counter Acne Treatment Products

Benzoyl peroxide and salicylic acid are the two most common active ingredients used in OTC acne treatments. They come in a variety of product types, including gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs. These OTC products can be purchased without a prescription. According to the FDA, the current product labels warn about less harmful irritations (for example, burning, dryness or itching) but do not warn about the risk of serious allergic reactions. Dr. Mona Khurana, an FDA medical officer, said, “It’s important that consumers know about [these reactions], and that they know what to do if they occur.”

Some of these products — for example, AVEENO CLEAR COMPLEXION CREAM CLEANSER, a salicylic acid blemish treatment — are advertised as “hypoallergenic,” suggesting that they are unlikely to trigger allergies. However, allergic reactions are still possible with such products.[2]

The FDA reported that through Jan. 28, 2013, the agency had received 131 reports of adverse reactions associated with use of these products from both consumers and manufacturers. The affected patients were ages 11 to 78. Many reports described severe allergy symptoms such as throat tightness, difficulty breathing, wheezing, low blood pressure, fainting or collapse. There were also a few instances of hives; itching of the face or body (even in skin areas where the product was not applied); and swelling of the eyes, face and lips. Approximately 40 percent of the reported reactions occurred minutes to 24 hours after use, but in some cases, the reactions occurred after a longer period. No deaths have been reported, but in nearly half of the cases, the patients required hospitalization.

After analyzing the reports, the FDA was unable to definitively confirm whether the adverse reactions were due to the products’ active ingredients, their inactive ingredients or both.

What You Can Do

The best way to check whether an acne product contains salicylic acid or benzoyl peroxide is to look at the “Active Ingredients” section of the label found on the product package.

The FDA recommends that consumers test an acne product’s safety when using it for the first time. New users should apply a small amount of the product to a small area of affected skin once daily for three days. If no discomfort occurs, you may follow the label’s directions for normal use.

If you experience symptoms of an allergic reaction after using a topical acne product, you should take the following precautions:

• Stop using the product and avoid using it again.


• Seek immediate medical attention if you experience throat tightness; swelling of the eyes, face, lips or tongue; lightheadedness; or difficulty breathing, as these may indicate a life-threatening allergic reaction.

You also should submit a report to the FDA’s MedWatch adverse event reporting program by downloading a form at www.fda.gov/MedWatch/report.htm or requesting one by phone at 800-332-1088.

References

[1] Food and Drug Administration. Topical acne products can cause dangerous side effects. June 25, 2014. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm402441.htm. Accessed August 17, 2014.

[2] http://www.aveeno.com/product/aveeno-+clear+complexion+cream+cleanser.do?sortby=ourPicks&from=fn%5D