FDA: Acne Products Can Cause Dangerous Side Effects

By Joe Gullo

Published 06/26 2014 11:57AM

Updated 06/26 2014 12:27PM

Credit: FDA
The Food and Drug Administration (FDA) is warning that some acne products an, in rare instances, cause severe allergic reactions that can be potentially life threatening. 

The FDA says certain acne products that contain the active ingredients benzoyl peroxide or salicylic acid can can life-threatening allergic reactions or severe irritations. The FDA classifies an active ingredient as a component that makes the medicine effective against an illness or condition.

The products under the warning are sold over-the-counter and are applied to the skin (topical). The FDA says products of concern are marketed under different brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. They are available as gels, lotions, face washes, solutions, cleansing pads, toners and face scrubs.

“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.”

Symptoms of a reaction may include throat tightness, shortness of breath, wheezing, low blood pressure, fainting or collapse. Isolated instances of 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 were also reported. 

About 42% of these reactions occurred within minutes to 24 hours of use. The affected persons ranged in age from 11 to 78 years.  The FDA says while no deaths have been reported, 44% of the cases required hospitalization.

The FDA says they can't determine whether the reactions were caused by the products' active ingredients, inactive ingredients, or a combination of both.

If a reaction occurs the FDA recommends the following:
  • Avoid using the product if you’ve had previous allergic or hypersensitivity reactions.
  • Stop using the product if you develop hives or itching of the face or body.
  • Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue; feel faint; or have difficulty breathing.
  • FDA encourages consumers to report any negative reactions or side effects from use of these products to the FDA’s MedWatch program.

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