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Potential for harm as a result of off-licence use of Hibitane (chlorhexidine 1%)

Published: 13/05/2016

Off-licence use of Hibitane (chlorhexidine 1%) has led to chemical burns when gauze swabs soaked in the cream have been left in situ.

The NHS England/RCOG Women’s Health Patient Safety Expert Group (PSEG) has been made aware of three separate incidents involving Hibitane (chlorhexidine 1%) cream which we are hereby drawing to your attention for local action.

A few cases of chemical site burns with Hibitane (chlorhexidine 1%) occurring when Hibitane-soaked packs have been left in situ for several hours for gynaecological procedures have been reported to the MHRA and through the National Reporting and Learning System. Hibitane is licensed as an antiseptic and lubricant in obstetric and gynaecological practice where licensed use is swabbing of the area before a procedure. However, the cases show potential off-label use, for example the product soaked in gauze and left overnight in situ. Clinicians should be aware that the use of Hibitane in this way is unlicensed and can cause harm.

The issue appears to have arisen following market unavailability of Proflavine Cream 0.1%.

Clinicians are asked to be aware of the above potential for harm if used off-licence. If you are aware of any similar use, with or without harm, please report this via your local risk management system which feeds into the National Reporting and Learning System. Please also report any cases of use resulting in harm to the MHRA through the Yellow Card system.