Summary Safety Review - Over-the-counter topical acne products containing either BENZOYL PEROXIDE or SALICYLIC ACID - Assessing the potential risk of serious allergic reactions (serious hypersensitivity reactions)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2015-12-10

Product

Over-the-counter topical acne products containing either BENZOYL PEROXIDE or SALICYLIC ACID

Potential Safety Issue

Assessing the potential risk of serious allergic reactions (serious hypersensitivity reactions)

Key Messages

  • Benzoyl peroxide and salicylic acid are medicinal ingredients in over-the-counter products that are applied to the skin (topical) to help treat acne.
  • As part of its routine health product monitoring, Health Canada carried out a safety review after the United States Food and Drug Administration identified a risk of serious allergic reactions (serious hypersensitivity reactions), linked to the use of over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid.
  • Health Canada's safety review concluded that there is evidence supporting a link between the use of over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid and serious hypersensitivity reactions, including anaphylactic reactions (which require emergency medical services). Health Canada will update the directions of use and warning sections of the Health Canada Acne Therapy Monograph for topical over-the-counter acne products containing either benzoyl peroxide or salicylic acid, and will issue an Information Update about these changes.

Overview

A safety review was carried out to evaluate a potential link between serious allergic reactions (hypersensitivity reactions) and over-the-counter acne products containing either benzoyl peroxide or salicylic acid applied on skin (topical). As part of its routine health product monitoring, Health Canada carried out a safety review after the United States Food and Drug Administration identified that a risk of rare but serious hypersensitivity reactions may be linked to the use of these products (including some life-threatening allergic reactions known as anaphylactic reactions). Similar acne products are available in Canada. Symptoms of a serious hypersensitivity reaction, including anaphylaxis, may include itchy hives with swelling of the face, eyes, lips, mouth or throat; difficulty of breathing; throat tightness or hoarseness; and fainting. An anaphylactic reaction is a potentially life-threatening type of serious hypersensitivity reaction.

Use in Canada

  • Benzoyl peroxide and salicylic acid are medicinal ingredients applied to the skin to help treat acne.
  • There are over 400 over-the-counter topical acne products marketed in Canada that 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.
  • Irritation and dryness of the skin are known side effects linked with the use of either benzoyl peroxide or salicylic acid. Signs of irritation include redness, burning, peeling and mild swelling. These known side effects are already described on the package information of over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid that are available for sale in Canada.

Safety Review Findings

  • At the time of the review, Health Canadaa received 10 Canadian cases of serious hypersensitivity reactions linked to the use of over-the-counter benzoyl peroxide products. Of these cases, 5 were anaphylactic reactions. For over-the-counter salicylic acid products, 16 Canadian cases of serious hypersensitivity reactions were received. Of these cases, 4 were anaphylactic reactions. In 2 of the anaphylactic cases, both benzoyl peroxide and salicylic acid products were used together.
  • 131 reports of serious hypersensitivity reactions linked to the use of either benzoyl peroxide or salicylic acid products were identified by the United States Food and Drug Administration. Fifty of these reports involved anaphylactic reactions.

Conclusions and actions

  • Health Canada's safety review concluded that there is evidence supporting a link between the use of over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid and serious hypersensitivity reactions.
  • As a result of the safety review findings, Health Canada will update the directions of use and warnings sections of the Health Canada Acne Therapy Monograph for over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid.
  • Although localized skin irritation appears to be the most common side effect reported, some users of these products may develop more serious and life-threatening hypersensitivity reactions, including anaphylaxis.
  • An Information Update will be published to inform healthcare professionals and consumers about the risk of serious hypersensitivity reactions and about changes to the product information of over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid. The Information Update will also provide the following consumer advice in the event of an anaphylactic reaction: if you develop severe itching and hives, with swelling of the face, eyes, lips, mouth or throat; difficulty breathing, throat tightness or hoarseness; and /or fainting, please seek emergency medical services.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.

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