Immediate allergies to chlorhexidine: A series of pediatric cases from the French pharmacovigilance database : Immediate allergies to chlorhexidine: series of pediatric cases from the French pharmacovigilance database - 28/09/24

Doi : 10.1016/j.arcped.2024.06.004

Claire Fontaine ^a,^⁎ , Cécile Rochefort-Morel ^b, Gwenaëlle Veyrac ^b, Elisabeth Polard ^c, Lucie-Marie Scailteux ^c
French Pharmacovigilance Network
^a Department of Pulmonology and Allergology, University Hospital Centre of Rennes, F-35000, Rennes, France
^b Pharmacovigilance, Pharmacoepidemiology and Drug Information Center, Department of Clinical Pharmacology, Nantes University Hospital, 44000, Nantes, France
^c Pharmacovigilance, Pharmacoepidemiology and Drug Information Center, Department of Clinical Pharmacology, Rennes University Hospital, 35033, Rennes, France

^⁎Corresponding author at: Department of Pulmonology and Allergology, University Hospital Centre of Rennes, F-35000, Rennes, France.Department of Pulmonology and AllergologyUniversity Hospital Centre of RennesRennesF-35000France

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Highlights

•	The largest series of pediatric cases of immediate hypersensitivity related to chlorhexidine, mostly represented by anaphylaxis (grades II–IV), confirmed by allergy tests and diagnosed in France.
•	In the setting of domestic use and misuse of chlorhexidine at home.
•	Hypothesis of sensitization, increases in case numbers, context of recurrence, and measures to prevent immediate allergies to chlorhexidine.

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Abstract

Background

Immediate allergic reactions to chlorhexidine have been clearly identified in numerous countries, generating governmental warnings worldwide.

Objectives

The aim of our study was to characterize (i) these allergies, which are less reported in pediatric populations, and (ii) the patient-at-risk profile so as to suggest preventive measures.

Methods

In association with the allergy department and the regional pharmacovigilance center in Rennes University Hospital, France, a multicenter retrospective, descriptive, and observational study was conducted using data from the national pharmacovigilance database for the period of January 1, 2010 to June 30, 2020. Immediate allergies to chlorhexidine cases based on a clinical history compatible with an immunoglobulin E (IgE)-mediated reaction, along with positive allergic testing, were analyzed.

Results

Of the 478 cases identified, 17 pediatric cases of immediate allergic reaction to chlorhexidine (13 cases of grades II–IV anaphylaxis) were retained for the analysis. For 58.8 % of these cases, a history of a previous more moderate reaction to the substance was identified. The reactions occurred most frequently in cases of domestic misuse (88.2 %, n = 15/17) of chlorhexidine to dress a wound. Recurrence was reported for two cases, later leading to severe reactions at each new exposure to the allergen, suggesting an aggravation mechanism.

Conclusion

The number of pediatric cases of immediate allergies to chlorhexidine has possibly been underestimated on account of insufficient knowledge of the allergy and in view of its common usage. Information on the method of caring for wounds among children and on the risk of allergic sensitization as well as exploring any unusual reaction to chlorhexidine application could reduce the number of allergic reactions.

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Keywords : Anaphylaxis, Children, Chlorhexidine, Domestic use, Immediate allergy, Prevention

Abbreviations : ADR, ANSM, CHX, EAACI, ENDA, FDA, IHS, RPVCs, SFMU, SFFPC, SF2H, SOCs, SOFCPRE, WHO