The Food and Drug Administration says that some over-the-counter acne products can cause severe hypersensitivity or allergic reactions and is warning consumers to discontinue use immediately and seek emergency medical attention if they experience such symptoms.
The reactions seem to be on the upswing, according to the agency’s review of reports from 1969 to early 2013.
The agency said in safety announcement that it has not determined whether the reactions are being triggered by the active ingredients in the products – benzoyl peroxide or salicylic acid – or by the inactive ingredients or a combination of the inactive and active ingredients.
The products include Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and private label store brands, and are sold as gels, lotions, face washes, solutions, cleansing pads, toners, and face scrubs, among other products, according to the agency.
The FDA has received reports stating that – within minutes to a day or longer of use – consumers have had hypersensitivity reactions that include throat tightness, difficulty breathing, or swelling of the eyes, face, lips, or tongue. Hives and itching are also indications of an allergic reaction.
From 1969 to January 2013, the agency identified 131 cases of hypersensitivity reactions, with the majority reported in 2012-2013. A total of 86% (113) of the cases were in women, and the reactions were reported in people aged 11-78 years.
There were no deaths, but 58 of the consumers were hospitalized. A total of 38 of the 131 cases (29%) were categorized as anaphylactic reactions, and the remainder were categorized as nonanaphylactic hypersensitivity. Almost half of the consumers said they had discontinued use after the reaction, the majority of whom reported some degree of recovery after discontinuing product use, with final outcomes unavailable for the rest. Four of the patients who used the product again reported a recurrence of the reaction.
The agency is encouraging manufacturers to add directions on testing for hypersensitivity to the labels of all OTC topical acne products. Some labels already include those instructions, which direct users to apply a small amount to one or two small affected areas of the skin for 3 days. If there is no reaction – topical or otherwise – then the product can be used according to the directions.
Consumers are also being urged to avoid using a product if they have previously experienced a hypersensitivity reaction with its use.
The FDA says that physicians should be aware that some topical prescription acne drug products also contain warnings about allergic reactions, including anaphylaxis.
Physicians can report adverse events involving OTC topical acne products to the FDA MedWatch program.
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