Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women

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Overview

Smecta® (dioctahedral smectite) is an edible natural clay used for the symptomatic treatment of diarrhoea.

 

Background of Safety Issue

NPRA has received information from the French National Agency for Medicines and Health Products Safety (ANSM) on the possible risk of lead passing through the blood of treated patients.

 

Following new international recommendations on drug-acceptable thresholds for heavy metals, the ANSM requested product registration holders of clay-based medicines to ensure that there is no risk of lead passing through blood in treated patients, and especially in children. For Smecta®, a clinical study was conducted with the results showing no risk of lead passing through blood in adults treated with Smecta® for 5 weeks. However, this risk cannot be ruled out in children aged under 2 years old. Following this, it is recommended that Smecta® is not administered to children aged 2 years old and below. The use of Smecta® is also not recommended in pregnant or lactating women due to the same reason1.

 

Adverse Drug Reaction Reports

NPRA has received a total of 9 reports with 12 adverse events suspected to be related to dioctahedral smectite/ diosmectite. Reported adverse events include rash, urticaria, angioedema and periorbital oedema. To date, no report related to lead poisoning following the use of Smecta® has been reported to the NPRA2.

 

Advice for Healthcare Professionals

  • Avoid use of Smecta® in infants and children aged below 2 years old. The reference treatment in acute diarrhoea is oral rehydration salts (ORS).
  • Smecta® is not recommended in pregnant or lactating women.
  • Please report any adverse drug reactions suspected to be associated to the use of Smecta® to the NPRA.

 

References:

  1. Agence Nationale de Sécurité du Médicament et des Produits de Santé, France (2019). Médicaments à base d’argile dans le traitement symptomatique de la diarrhée aigüe chez l’enfant - Point d'information.
  2. The Malaysian Adverse Drug Reaction database, NPRA [Accessed: October 2019].

 

 

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Tuesday 19 November 2019, 13:10:12.
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MOH Pharmacy Staff

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