Allergic reactions to OTC acne products prompt 3 updates by Health Canada

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Health Canada released a safety review on Dec. 10, 2015 warning of serious allergic and hypersensitivity reactions to over-the-counter (OTC) topical acne products containing either benzol peroxide or salicylic acid.

Ten cases in Canada of serious hypersensitivity reactions—severe itching and hives, with swelling of the face, eyes, lips, mouth or throat; difficulty breathing; throat tightness or hoarseness; and/or fainting—linked to the use of OTC benzoyl peroxide products were reported to Health Canada. Of these cases, five were anaphylactic reactions. For OTC salicylic acid products, 16 Canadian cases of serious hypersensitivity reactions were reported, including four anaphylactic reactions. In the U.S., the Food and Drug Administration identified 131 cases of serious hypersensitivity reactions linked to the use of either benzoyl peroxide or salicylic acid products.

“Non-prescription acne products containing benzoyl peroxide or salicylic acid are applied on the skin to help treat acne. Common side effects of benzoyl peroxide and salicylic acid that are included on the labels or package information of marketed Canadian products are localized skin irritation and dryness. Signs of irritation include redness, burning, peeling, and mild swelling,” stated Health Canada in an information update.

As a result of the safety review Health Canadais updating the Health Canada Acne Therapy Monograph to include:

  • Instructions for sensitivity testing to help determine whether a new user of an acne product may be sensitive or allergic to the product;

  • Updated warnings relating to possible skin reactions and allergic reactions, and what consumers should do; and

  • A warning that the product should not be used if someone is allergic to any of the ingredients of the product, including benzoyl peroxide or salicylic acid.

Health Canada reports that there are over 400 OTC topical acne products marketed in Canadathat contain either benzoyl peroxide or salicylic acid. These products generally contain 2.5% to 5% benzoyl peroxide or 0.5 to 2% salicylic acid, and are available in various forms, including soaps, creams, gels, and lotions.



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