E-DRUG: Chlorhexidine aqueous solution or gel (10ml) Reports of serious eye injury due to errors in administration
--------------------------------------------------------------------------------------------
25 February 2019
Information Exchange System
Alert No. 133
https://www.who.int/medicines/regulation/medicines-safety/alert133_chlorhexidine.pdf?ua=1&ua=1
WHO has been made aware of multiple, recent reports of eye injury,
including blindness, with the use of chlorhexidine gluconate 7.1%, in nine
countries in sub Saharan Africa.
Chlorhexidine gluconate (CHX), available as an aqueous solution or as a gel
(delivering 4% chlorhexidine), is used in umbilical cord care, and is
listed in the WHO Essential Medicines Listi. WHO recommends daily
chlorhexidine (4%) application to the umbilical cord stump during the first
week of life for newborns who are born at home in settings with high
neonatal mortality (neonatal mortality rate >30 per 1000). Clean, dry cord
care is recommended for newborns born in health facilities, and at home in
low neonatal mortality settings.
Use of chlorhexidine in these situations
may be considered only to replace application of a harmful traditional
substance such as cow dung to the cord stump. The use of CHX is being
implemented in many countries (South Asia and sub-Saharan Africa) as part
of a package of essential newborn interventions to reduce the incidence of
omphalitis ii.
CHX causes serious harm if mistakenly applied to the eyes, resulting in
severe eye injuries. Over forty (40) cases of such incorrect administration
are recorded, either as media reports, or in the literature, since 2015.
Injuries associated with both the liquid and gel (ointment) formulations
have been reported when CHX was mistaken for eye drops or ointments.
The present Alert is being issued to warn all stakeholders involved in the
umbilical cord care programmes about this potential misadministration and
risk of serious injury with CHX. All healthcare professionals, caregivers
and others involved in its distribution, use and / or administration are
advised to take all necessary measures and precautions to ensure its
correct use and administration.
Suggestions to National Neonatal and Reproductive Health Programmes and/or
Regulators include the following:
- Assess what products are part of the newborn package and select the
optimal primary container/dosage form for CHX or modify the design of the
container to distinguish the product from other medicines typically used
for newborns.
- Update the product label with appropriate information on the safe use of
the product.
- Develop more detailed instructions for users (flyers, posters,
pictorials etc.) that are culturally appropriate and easy to understand, to
ensure correct use of the product.
- Train health care professionals who interact with mothers and/or provide
the product to ensure the full understanding of the indications and
contraindications for use and application methods.
All stakeholders are advised to remain alert to incidents of eye injury
with CHX in their settings and to report these to their National Regulatory
Authority (NRA). Member States are reminded that adverse events associated
with the use of any medicinal product should be reported to the National
Regulatory Authority.
For any questions relating to this alert please contact Dr S Pal (pals@who.int) or Dr J Simon (simonjo@who.int).
i https://www.who.int/medicines/publications/essentialmedicines/en/
ii https://www.who.int/maternal_child_adolescent/documents/postnatal-care-recommendations/en/
(page 3)
Bruneton Carinne <carinne.bruneton@gmail.com>
E-med@healthnet.org