Dépakine: a barcode defect on a small number of boxes could lead to a "risk of overdose"alerts the ANSM
The National Medicines Safety Agency (ANSM) alerted Thursday April 4 about a barcode defect “on a small number of boxes” of the antiepileptic drug Dépakine, leading to “risk of overdose”. Sanofi assured that a “large part of the boxes” affected by this defect had however “been out of the loop”according to a spokesperson at AFP.
In a communicatedthe ANSM specifies having been informed by the French laboratory “from a fault of the ‘damatrix’ [code-barre flashé par la pharmacie pour identifier le médicament] on a small number of boxes of Dépakine Chrono 500 mg” with prolonged release which concern “lot 4R112”. “On non-compliant boxes, the information contained in the barcode is incorrect and corresponds to Dépakine 200 mg, gastro-resistant immediate release tablet.explains the medicine policeman.
Certain boxes of Dépakine 500 mg (tube of 30 tablets) could thus be delivered instead of boxes of Dépakine 200 mg (tube of 40 tablets), “resulting in a risk of overdose for the patient, particularly in children and patients with renal insufficiency”, warns the ANSM. The pills of both strengths did not “not the same shape”underlines Sanofi.
Distribution of the boxes in question began on March 22 and patients who were issued a box of the lot affected by this defect will be contacted by their pharmacist. This must inform patients “that they should contact their doctor if they have taken Dépakine chrono 500 mg instead of Dépakine 200 mg, particularly if they (or their child) experience unusual symptoms such as digestive problems (nausea, vomiting, diarrhea, abdominal pain) or drowsiness”, according to the ANSM. Dépakine was at the center of a health scandal in 2015 following malformations in children of women receiving treatment during pregnancy.
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