On Wednesday morning, June 25, the U.S. Food and Drug Administration (FDA) made a safety announcement warning the public that certain over-the-counter topical acne products could cause rare, but serious and potentially life-threatening allergic reactions.
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The topical acne products of concern are marked under various brand names and include:
- Proactiv
- Neutrogena
- Oxy
- Ambi
- Aveeno
- Clean & Clear
- MaxClarity
The products are available as gels, lotions, face washes, cleansing pads, face scrubs and more.
Anyone who experiences hypersensitivity reactions such as difficult breathing, feeling faint of throat tightness should seek medical attention right away. Consumers should stop using the product if they develop hives or itches.
The reactions may occur within minutes or up to a day after the products have been used. The FDA is unable to determine if the reactions were triggered by the ace products active ingredients, inactive ingredients or a combination of both.
Manufacturers of OTC topical acne drug products are being given the option to add label directions for sensitivity testing for new users of their products. The FDA is recommending that consumers who opt to use these products for the first time apply a small amount to one or two small areas of the skin for three days, if no discomfort occurs then the product may be used according to the directions.
The FDA intends to continue monitoring this safety issue and will work with manufacturers regarding any future label changes.