Summary Safety Review - Topical Antiseptic Non-Prescription Chlorhexidine Products - Assessing the Potential Risk of Serious Allergic Reactions (hypersensitivity reactions)

Summary Safety Review - Topical Antiseptic Non-Prescription Chlorhexidine Products - Assessing the Potential Risk of Serious Allergic Reactions (hypersensitivity reactions) This safety review was carried out to look at the potential link between non-prescription topical antiseptic chlorhexidine products and serious allergic reactions, and to determine if there is a need for additional labelling requirements. Symptoms of a serious allergic reaction, including anaphylaxis, may include itchy hives with swelling of the face, eyes, lips, mouth or throat; difficulty breathing; throat tightness or hoarseness; and fainting. An anaphylactic reaction is a serious and potentially life-threatening hypersensitivity reaction. 2024-05-10 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetySummary Safety ReviewTopical Antiseptic Non-Prescription-Chlorhexidine Productsassessingpotential riskSerious Allergic Reactionshypersensitivity reactions Summary Safety Review - Topical Antiseptic Non-Prescription Chlorhexidine Products - Assessing the Potential Risk of Serious Allergic Reactions (hypersensitivity reactions)HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/summary-safety-review-topical-antiseptic-non-prescription-chlorhexidine-products-potential-risk.html Summary Safety Review - Topical Antiseptic Non-Prescription Chlorhexidine Products - Assessing the Potential Risk of Serious Allergic Reactions (hypersensitivity reactions)HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/examens-innocuite/resume-examen-innocuite-produits-antiseptiques-topiques-base-chlorhexidine-vente-libre-evaluation.html

This safety review was carried out to look at the potential link between non-prescription topical antiseptic chlorhexidine products and serious allergic reactions, and to determine if there is a need for additional labelling requirements. Symptoms of a serious allergic reaction, including anaphylaxis, may include itchy hives with swelling of the face, eyes, lips, mouth or throat; difficulty breathing; throat tightness or hoarseness; and fainting. An anaphylactic reaction is a serious and potentially life-threatening hypersensitivity reaction.

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