FDA Warns Acne Products Can Be Dangerous

The FDA warned consumers and physicians Wednesday that some over-the-counter acne products can cause rare but sometimes life-threatening reactions.

The agency said that over the last 40 years it has received 131 reports from users and manufacturers about adverse reactions to products like Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear, which contain the ingredients benzoyl peroxide or salicylic acid. About 42% of the bad reactions happened within 24 hours of use, and while no deaths have been reported, 44% of the cases resulted in hospitalizations.

The FDA said 40% of the cases had symptoms similar to an allergy attack, like a tight throat, shortness of breath, wheezing, low blood pressure, fainting and collapsing. Some users have broken out in hives, and had facial swelling. The acne treatments come in many forms, including gels, lotions, face washes, cleansing pads, and face scrubs.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” Dr. Mona Khurana of the FDA said in a statement. “It’s important that consumers know about them, and that they know what to do if they occur.”

The FDA said it’s continuing to monitor the products’ safety, and that it’s also urging acne product makers to use a drug label that advises users on how to test the product’s safety on their own skin. For instance, applying a small amount to an affected area for three days before using normally is one way Khurana said consumers can be cautious.