Despite warnings in the medicinal product information, incorrect use of Octenisept®, which may result in severe tissue damage, continues to occur. Prolonged contact with the active substance octenidine can cause swelling and tissue damage; it should therefore not be used to irrigate gingival pockets, root canals or wound cavities. The wound and mucous membrane disinfectant is only intended for topical use.
Octenisept® and incorrect use to irrigate deep wounds
Incident data |
Description |
|---|---|
Year: 2020 Age: Child Sex: Female Medicinal product: Octenisept Active substances: Octenidine, phenoxyethanol Indication: Wound disinfection ADRs: Cellulitis, myositis, fasciitis of the plantar muscles, medication error Outcome: Recovering |
A girl was brought to the emergency department after a nail entered the sole of her foot while she was walking. The wound was irrigated liberally with Octenisept and the patient was discharged home with prophylactic antibiotic medication,. Two days later, an oedema with localised redness formed in the area of the lesion. Since an infection was suspected, intravenous antibiotic treatment was initially started. As her results did not improve, an MRI examination was performed. This revealed myositis as well as perimuscular fasciitis of the plantar muscles without abscess formation. After several weeks of hospitalisation with antibiotic treatment, immobilisation and anti-inflammatory measures, the girl was discharged. The cause was categorised not as infectious, but as inflammatory as a consequence of the initial deep irrigation with Octenisept. |
Summary and recommendation
Tissue necroses, erythema and persistent oedema are possible adverse drug reactions (unknown frequency) which may occur after irrigation of deep wounds with Octenisept.
Both the medicinal product information (“Warnings and precautions” section, see boxed warning) and the text on the primary packaging state that Octenisept must not be introduced into deep tissue using a syringe and is only intended for topical use (application by swab or spraying).
Despite this warning, cases are still being reported in which irrigation of deep wounds under pressure has led to severe complications with tissue damage.
Statutory duty of healthcare professionals to report adverse drug reactions (ADRs)
In Switzerland, healthcare professionals who are authorised to dispense or administer medicinal products are obligated to report severe and/or previously unknown side effects. Reports to Swissmedic can be entered and sent in the Electronic Vigilance Reporting Portal “ElViS” (ElViS login).
Supplementary information
Medicinal product information
(www.swissmedicinfo.ch)
Reporting adverse drug reactions
Electronic reports via the ElVis portal