Other safety alerts
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| Singapore: Smecta®: Restriction of treatment of acute diarrhoea to children >2 years of age and adults, and recommendation against use in pregnant and breastfeeding women |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Emerging Pharma to inform healthcare professionals of changes to the use of Smecta® (dioctahedral smectite or diosmectite) in children and in pregnant and breastfeeding women.
Elements such as lead occur naturally in soil and trace amounts of these elements can be found in food and water. Naturally occurring diosmectite (the clay from which Smecta® is produced) contains trace amounts of lead too. In compliance with international guideline, the product owner of Smecta® (Ipsen) has conducted a data review and a clinical study which did not find evidence of any actual risk related to lead in adult patients with chronic diarrhoea treated with Smecta® for 5 weeks. Other data developed by Ipsen confirmed the safety profile of Smecta® in the children population with treatment duration of up to 7 days. As a precautionary measure and taking into consideration the lack of data in pregnancy and breastfeeding, Ipsen has decided to restrict the indication of Smecta® for treatment of acute diarrhoea to children 2 years of age and above and in adults, and to recommend against the use of Smecta® in pregnant and breastfeeding women.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/smecta-restriction-of-treatment-of-acute-diarrhoea-to-children-2-years-of-age-and-adults-and-recommendation-against-use-in-pregnant-and-breastfeeding-women
In Hong Kong, there are 2 registered pharmaceutical products containing dioctahedral smectite, namely Smecta Sachet (HK-34268) which is registered by Beaufour Ipsen International (Hong Kong) Limited and Monotin Powder 3g/sachet (HK-58612) which is registered by Bright Future Pharmaceuticals Factory. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to dioctahedral smectite. In light of the above HSA’s announcement, letters to inform local healthcare professionals will be issued. The DH will continue to remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Friday, Mar 20, 2020
Issued at HKT 16:00
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