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Chlorhexidine 7.1% Digluconate can Result in Serious Eye Injury to Newborns if Incorrectly Administered

The WHO has issued an alert to medical professionals involved in the care of newborn umbilical cords: CHX, or, chlorhexidine 7.1% digluconate, has caused serious eye injury to newborn babies in nine sub-Saharan African countries when the ointment was erroneously applied to the eyes. Some cases have resulted in blindness.

As one of the WHO’s Essential Medicines, chlorhexidine is available in many countries as an intervention intended to minimise the occurrence of omphalitis 2. The use of CHX is part of a package of newborn medical interventions available in South Asia and sub-Saharan Africa. CHX comes in both aqueous and gel form, and the gel delivers 4% chlorhexidine.

According to WHO recommendations, CHX is applied to the umbilical cord stump of newborn babies born at home, in settings where the mortality rate for newborns is greater than 30 deaths per 1000 births. Newborns born in medical or health facilities or at home where neonatal mortality is low receive CHX only to take the place of a more dangerous traditional substance. In these contexts, cord care involves keeping the umbilical cord stump clean and dry.

Since 2015, over forty cases of eye injuries caused by CHX have been recorded, including blindness. In these situations, the chlorhexidine was mistakenly thought to be eye drops or other ointment.

A series of suggestions has been made to the National Neonatal and Reproductive Health Programmes and/or Regulators in response to the reports of the eye injuries.

One of the four suggestions mentioned in the alert from the WHO concerns the packaging of CHX. An assessment of all the medicinal products available in the neonatal package and the containers in which they appear could lead to a new design that distinguishes CHX from other medicines for newborns.

As well, the labeling of chlorhexidine could include more safety information as well as more details for use. Culturally appropriate instructions accompanied by clear visual aids and other educational materials will help clarify essential information and ensure the correct administration of CHX.

Finally, health professionals who work with new mothers and their newborn babies can be trained to understand the proper usage and application of chlorhexidine as well as the risks.

The WHO asks that any instances of eye injury due to the misapplication of CHX be treated like any other adverse reaction to a drug or medicine and be reported to the National Regulatory Authority.

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