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Supreme Court Decision Could Stop Medical Device Makers from Citing Preemption

Jun 30, 2014

The U.S. Food and Drug Administration (FDA) has warned that some over-the-counter topical acne products can lead to rare but serious hypersensitivity reactions. In a Safety Announcement issued Wednesday, the agency said that consumers using these products should seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness, difficulty breathing, feeling faint or swelling of the eyes, face, lips or tongue. If hives or itching occurs, then consumers should stop using the product as well.

The FDA’s warning affects numerous acne products in the market containing benzoyl peroxide and salicyclic acid. Examples of these products include brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

It is unclear whether the hypersensitivity reactions are caused by the active ingredients, the inactive ingredients or a combination of both, the FDA said. The hypersensitivity reactions are different from local skin irritation that may occur after the product is applied; these symptoms, such as redness, burning, dryness, itching, peeling or slight swelling, are already mentioned on the Drug Facts label. 

Although the hypersensitivity reactions are rare, they can be life-threatening. Out of the 131 “hypersensitivity reactions with serious outcomes,” that the FDA identified through its adverse event database, 44 percent required hospitalization and 38 percent were classified as anaphylactic reactions that involved respiratory or cardiovascular issues. Other patients suffered severe reactions in the skin or mucous membranes. Eighty-six percent of affected patients were female and the average age of the patient was 32 years old. The reaction can happen minutes after the product is used or show up a day after or longer. Most of the identified cases were reported in 2012.

Four patients said that when they used the product again, the hypersensitivity reaction recurred.

Some products include instructions for sensitivity testing. The FDA encourages consumers to follow these instructions to prevent an allergic reaction from occurring. The agency also advised manufacturers to place these instructions on their labels if it is not already present. To test for sensitivity, consumers are told to place a small amount of the product on the affect area of the skin for 3 days to see if there is a reaction. If no discomfort occurs, the product can be used as directed.

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