Copy of Advice from FDA: Topical Acne Products Can Cause Dangerous Side Effects


Last summer, the US Food and Drug Administration (FDA) issued a warning that certain over-the-counter (OTC) topical acne products can cause a severe allergic reaction. These cases are rare, but they can be life-threatening.

The (OTC) acne products involved contain the active ingredients benzoyl peroxide or salicylic acid and are listed in the products' Drug Facts label. The products are sold under different brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. They are available as gels, lotions, cleansing pads, toners, face washes and scrubs.

There have been 131 cases of allergic reactions reported to FDA from 1969 to 2013. In 42% of these cases, a reaction occurred within minutes to 24 hours after use. Severe allergy symptoms occurred in 40% of the cases. These symptoms included throat tightness, shortness of breath, wheezing, low blood pressure, fainting, or collapse. In some cases, symptoms also included hives, itching of the face and body, and swelling of the face, eyes, and lips. No deaths have been reported, but 44% of the cases required hospitalization. At this time, it has not been determined if the reaction is caused by the products' active ingredients (medicines), the inactive ingredients (contents of the lotion, gel, or liquid that is not a medicine), or a combination of both.

Here's what you can do: Read the Drug Facts label on the acne product before purchasing it. If it contains benzoyl peroxide or salicylic acid, FDA recommends applying a small amount to the affected area for 3 days. If no reaction or discomfort occurs, the product can be used as directed. If a reaction occurs, stop using the product. Seek medical attention immediately if you develop throat tightness or swelling of the eyes, face, lips, or tongue; feel faint; or have difficulty breathing. If you had a previous reaction to a product that contained benzoyl peroxide or salicylic acid, do not use products that contain those ingredients again.

Created on July 24, 2015