Smecta: Not for Children Below 2 Years
Drug Safety Update
The International Council for Harmonization (ICH) has established a guideline "ICHQ3D" on the levels of certain elements in medicines. The guideline aims to limit exposure to these elements, as the general population is exposed to these elements from various sources over their lifetime.
Since elements such as lead occur naturally in soil, naturally occurring diosmectite - the clay from which Smecta is produced - contains trace amounts of lead too.
In 2019, as a precautionary measure, the company decided to remove the use of Smecta for acute diarrhoea in infants and children under 2 years, in line with the recommendations to use oral rehydration solutions (ORS) as the preferred treatment for this age category.
- For the same reason, the use of Smecta in pregnant and breastfeeding women is also restricted.
NOTE: To date, there have been no report of lead poisoning following the use of Smecta reported to the NPRA.
Antidiarrheal Agents in Paediatric Population
- Antidiarrheal agents are not recommended as part of the management of acute gastroenteritis in infants and children because they do not address the underlying cause (i.e. do not treat the infection) and have a risk of serious adverse effects.
- Loperamide - Serious cardiovascular events (such as QT prolongation, torsades de pointes and cardiac arrest), including fatalities, have been reported in association with large overdoses of loperamide.
- Atropine and Diphenoxylate - Cases of severe respiratory depression and coma, leading to permanent brain damage or death have been reported in patients <6 years old.
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