- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Anaesthesia and intensive care and Paediatrics and neonatology
A European review has considered MHRA evidence together with additional information from spontaneous reporting and published literature.
Article date: November 2014
In June 2014 we informed you of the risk of severe chemical injuries associated with the use of both alcohol-based and water-based chlorhexidine solutions for skin disinfection in premature infants. This was based on Yellow Card reports and reports identified in the literature. A European review has since considered the MHRA evidence together with additional information from spontaneous reporting and published literature. This European review confirmed our findings. The risk appears to be higher in infants born before 32 weeks of gestation than in full term infants and in the first 2 weeks of life than in later life.
The advice for healthcare professionals remains the same as that published in June 2014:
Advice for healthcare professionals
- When using alcohol-based or water-based chlorhexidine solutions on premature infants, bear in mind the risk of severe chemical injuries
- Use the minimum amount of chlorhexidine solution required and do not allow the solution to pool. Remove any excess solution and any soaked materials, drapes, or gowns from the skin
- Monitor patients frequently to detect and manage cutaneous side effects at an early stage
- Please report any adverse events through the Yellow Card Scheme: www.mhra.gov.uk/yellowcard
Single-use containers preferred
Chlorhexidine solutions are available in single-use containers or multiple-use ones. Use single-use containers where possible. There is a danger of accidentally using too much solution from a multiple-use container.
Article citation: Drug Safety Update volume 8 issue 4, November 2014: S3