The journal of health professionals Prescrire advises against the use of diosmectite-based drugs, such as Smecta, for children as for adults.
“Given the very limited interest of these drugs, it is best to do without them regardless of age and clinical situation.” This is the conclusion of the review health professionals Prescribe concerning clay-based drugs, called diosmectite, such as Smecta, Diosmectite Mylan or Actapulgite.
These drugs are regularly prescribed for digestive disorders such as diarrhea, heartburn or gastric reflux. They contain clays for medical purposes, extracted from the ground which, via their absorbent properties, capture the impurities of the earth including lead.
In 2018, the National Agency for the Safety of Medicines and Health Products (ANSM) had already warned of the dangers of these drugs in children under 2 years old.
After blood lead measurements (i.e. the presence of lead in the blood) on adults, the ANSM concluded that the presence of lead in these clays for medical purposes would expose children under two years of age treated for 7 days at a blood lead level of more than 50 micrograms per litre. This level of lead concentration in the blood can be synonymous with neurobehavioral disorders.
Prohibited in children and strongly discouraged in pregnant women
These measures resulted in a modification of the official information concerning these medicinal products. The Smecta and Diosmectite Mylan specialties are no longer authorized for children under 2 years of age. Actapulgite and Bedelix are no longer authorized in children. And the other clay-based specialties remain reserved, as before, for adults and children over 15 years of age.
The drug safety agency also specifies that the use of diosmectite is not recommended for pregnant or breastfeeding women.
In view of these recent data, the advice of the journal Prescrire is therefore to do without these drugs entirely.
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