The drug authorities have banned the use of dioctahedral smectite-containing drugs for acute diarrhea for children aged 2 or less, pregnant and nursing women, due to safety issues.
If the child is aged over 2, the medication period will be limited to seven days maximum.
|Daewoong Pharmaceutical’s acute diarrhea treatment Smecta|
The Ministry of Food and Drug Safety on Tuesday issued a safety letter over eight authorized pharmaceutical products including Smecta that contain dioctahedral smectite, as a follow-up of the measure by France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM).
ANSM conducted a clinical trial on adults to test dioctahedral smectite’s possible risk of lead poisoning.
Although there was no risk of lead traces in adults, the agency did modeling for pediatric users based on the result of the study. The ANSM concluded that it could not rule out the risk of lead poisoning in children under two.
As a precautionary measure, the regulator banned the use of the drug on children under two, the pregnant, and nursing mothers, and added the same warning to the drug’s manual.
To treat acute diarrhea of children under two, the drug should be administered within seven days. If the patient was taking the medication, he or she should not discontinue the medication but consult with a doctor or a pharmacist.
Adults have no limitation in the use of dioctahedral smectite to relieve pain in esophagus, stomach, and duodenum, or to treat acute/chronic diarrhea.
The food and drug safety ministry said it was proceeding to add the warning to the product manual. Those who have an opinion about the change in approval condition can submit the reason to the ministry by May 8.
The eight dioctahedral smectite-using medicines are Smecta Suspension (Daewoong Pharmaceutical), Fotagel Suspension (Daewon Pharmaceutical), Dytop Suspension (Sama Pharm), Disbec Suspension (DongKoo Bio & Pharma), Unimecta Powder (Unimed Pharm), Shumacton Suspension Sachet (Il-yang Pharm), Diocta Suspension (Daewoong Bio), and Dextra Suspension (Youngil Pharm).