Re-evaluation of polihexanide use in wound antisepsis in order to clarify ambiguities of two animal studies.

Authors:
Axel Kramer
Axel Kramer
Institute of Hygiene and Environmental Medicine
Germany
Thomas Eberlein
Thomas Eberlein
Paracelsus Medical University
Austria
Gerald Muller
Gerald Muller
Institute of Hygiene and Environmental Medicine
Joachim Dissemond
Joachim Dissemond
Universitätsklinikum Essen
Germany
Ojan Assadian
Ojan Assadian
Medical University of Vienna
Austria

J Wound Care 2019 Apr;28(4):246-255

Consultant Clinical Microbiology and Infection Control, Consultant Infectious Diseases and Tropical Medicine, Department for Hospital Epidemiology and Infection Control, Medical University of Vienna, Austria.

Objective: Due to classification of the agent polihexanide (PHMB) in category 2 'may cause cancer' by the Committee for Risk Assessment of the European Chemicals Agency in 2011, the users of wound antiseptics may be highly confused. In 2017, this statement was updated, defining PHMB up to 0.1% as a preservative safe in all cosmetic products. In the interest of patient safety, a scientific clarification of the potential carcinogenicity of PHMB is necessary.

Methods: A multidisciplinary team (MDT) of microbiologists, surgeons, dermatologists and biochemists conducted a benefit-risk assessment to clarify the hazard of antiseptic use of PHMB.

Results: In two animal studies, from which the assessment of a carcinogenic risk was derived, PHMB was administered orally over two years in extremely high concentrations far above the NO(A)EL (no-observed-(adverse-) effect level) in rats and mice. Feeding in the NO(A)EL range resulted in no abnormal effects. In one male in the highest dose group of 4000ppm PHMB, an adenocarcinoma was found, which the author attributed to chronic inflammation of the colon with systemic atypical exposure. The increasing incidence of hemangiosarcomas highly probably resulted from increased endothelial proliferation, triggered by the exceedingly high dosage fed, because PHMB is not genotoxic and there is no evidence for epigenetic effects.

Discussion: It is well known that PHMB is not absorbed when applied topically. Considering the absence of genotoxicity and epigenetic effects together with the interpretation of the animal studies, it is the consensus of the multidisciplinary experts that a carcinogenic risk from PHMB-use for wound antisepsis can be ruled out.

Conclusion: On this basis and considering their effectiveness, tolerability and clinical evidence, the indications for PHMB based wound antiseptics are justified.

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Source
http://dx.doi.org/10.12968/jowc.2019.28.4.246DOI Listing

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April 2019
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References

(Supplied by CrossRef)
Article in Br J Oral Maxillofac Surg
Below H et al.
Br J Oral Maxillofac Surg 2016

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