SEVERE ALLERGIC REACTIONS TO ACNE TREATMENTS

July 2, 2014

On June 25, 2014, the Food and Drug Administration (FDA) issued a Consumer Safety Update warning that over-the-counter acne treatments containing benzoyl peroxide (for example, PROACTIV, OXY SPOT TREATMENT) or salicylic acid (for example, NEUTROGENA OIL-FREE ACNE WASH, OXY DAILY DEFENSE WASH, AMBI EVEN & CLEAR EXFOLIATING WASH, AVEENO CLEAR COMPLEXION CREAM, CLEAN & CLEAR ADVANTAGE ACNE SPOT TREATMENT) can cause rare but serious and potentially life-threatening allergic reactions.

Read the complete consumer update: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm402441.htm

Acne treatments containing benzoyl peroxide and salicylic acid come in a variety of product types, including gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs. They can be purchased over the counter, without a doctor’s prescription. The current product label warns about less-harmful irritations (for example, burning, dryness, or itching), but does not warn about the risk of serious allergic reactions.

Some products containing benzoyl peroxide or salicylic acid — 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.

The FDA reported that through January 28, 2013, the agency had received 131 reports from both consumers and manufacturers of adverse reactions associated with use of these products. 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 person did not apply the medication); and swelling of eyes, face, and lips. Approximately 40 percent of the reported reactions occurred within minutes or in the first 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.

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 Drug Facts label on the product package.

The FDA recommends that consumers test a product’s safety when using it for the first time. New users should apply a small amount of the product to a small affected area for three days. If no discomfort occurs after using the product for three days, the consumer 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; experience swelling of the eyes, face, lips, or tongue; feel lightheaded; or have difficulty breathing, as these may indicate a life-threatening allergic reaction.

You also should report such adverse events to the FDA’s MedWatch program online by visiting https://www.accessdata.fda.gov/scripts/medwatch/.