Depakine: Barcode defect on small number of boxes raises fears of patient overdose risk

The National Medicines Safety Agency (ANSM) warned on Thursday of a barcode defect “on a small number of boxes” of the anti-epileptic drug Depakine, resulting in a “risk of overdose”. Sanofi assured that “the majority of the boxes” affected by the defect “were rendered unusable,” according to an AFP spokesperson.

In a press release, ANSM indicates that a French laboratory informed it “of a datamatrix defect (a bar code issued by a pharmacy to identify the drug) on ​​a small number of boxes of Depakine Chrono 500 mg” with a long expiration date. release that concerns “Lot 4R112”.

“On the non-compliant boxes, the information contained in the barcode is incorrect and corresponds to gastro-resistant Depakine 200 mg immediate release tablet,” explains the police officer.

Tablets of two dosages “not the same shape”

Thus, some boxes of Depaquine 500 mg (tube of 30 tablets) may be delivered instead of boxes of Depaquine 200 mg (tube of 40 tablets), “resulting in a risk of overdose for the patient, especially in children and patients with renal failure.” “, warns ANSM. The two strengths of the tablets are not “the same shape,” Sanofi emphasizes.

Distribution of the boxes in question began on March 22, and patients who were issued a box from a batch with this defect will be contacted by their pharmacist.

Patients should be advised that they should consult a doctor if they have taken Depakine Chrono 500 mg instead of Depakine 200 mg, especially if they (or their child) experience unusual symptoms such as digestive disorders (nausea, vomiting, diarrhea, abdominal pain ). ) or drowsiness,” according to the ANSM.

Depakine was at the center of a health scandal in 2015 due to malformations in the children of women treated during pregnancy.