Clay-based medicines such as Smecta, widely administered in case of gastro, are possibly dangerous for children because of their lead content.
Beware of Smecta for children. While clay-based medicines are regularly used to relieve intestinal and digestive disorders, or diarrhea, they would not be without risk for little ones. “Clays for medical purposes are extracted from the ground. By their adsorbent properties, they capture impurities from the ground, including lead”, warns the medical journal Prescribe.
Not only has the effectiveness of these remedies not been “demonstrated” but in addition, according to the French Medicines Agency (ANSM), this lead contamination would expose children under 2 years of age treated for 7 days with disomectitis ( form of white clay used on prescription or in self-medication as an antidiarrheal) to a blood lead level reaching more than 50 micrograms per liter, reveals the report. However, “such blood lead is known to expose to neurobehavioral disorders”.
Then, in early 2019, the ANSM announced changes to official clay drug information, recalls the press release. “The ANSM has asked the laboratories marketing clay-based medicines to ensure that there is no risk of lead passing into the blood in the patients treated, and more particularly in children. In response, the laboratories IPSEN provided a clinical study, the results of which indicate that there is no risk of passage of lead in the blood in adults treated with Smecta® (diosmectite) for 5 weeks. This risk cannot be excluded in children under 2 years of age. Consequently, it is recommended as a precautionary measure to no longer administer Smecta® or its generic Diosmectite Mylan for children under 2 years old”, noted the agency in February on its website.
Pregnant women also concerned by these recommendations
Also, the specialties Smecta° and Diosmectite Mylan° are no longer authorized for babies under 2 years of age or younger. Actapulgite° and Bedelix° are no longer allowed at all for children. And a contraindication should soon be added for children for Gastropax°.
But, besides children, clay-based drugs are not recommended for pregnant or breastfeeding women, recalls Prescribe. “Given the very limited interest of these drugs, it is best to do without them regardless of age and clinical situation”, concludes the report.
In case of gastro, it is especially necessary to take measures of hygiene and food. It is essential to wash your hands regularly for at least 15 seconds and to avoid physical contact with uninfected people as much as possible. In terms of food, it is recommended to eat starchy foods (well-cooked rice, white pasta…), lean fish cooked in water, grilled lean meat or ham, cooked carrots and cheeses cooked dough. If the symptoms persist in children under two years of age, the reference treatment is oral rehydration solution (ORS), recalls the ANSM. These are powder sachets, available in pharmacies without a prescription, to be poured into a bottle of water.
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