Dépakine: A barcode error on some boxes can lead to an overdose

Dépakine: 500 mg boxes identified as 200 mg boxes

Marketed since 1967, sodium valproate (Dépakine®) was initially marketed as an antiepileptic drug. Its indication was then extended to bipolar disorders. It is estimated that 80,000 people are treated on average each year in France with this molecule, even if these figures are decreasing for women of childbearing age, following the demonstration of its teratogenic effects causing a health scandal.

The national medicines safety agency (ANSM) declares having been informed by the Sanofi laboratory of a barcode defect (datamatrix flashed by the pharmacy to identify the medicine) on a small number of boxes of Dépakine Chrono 500 mg from 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”.

Risk of overdose, particularly for children and people with kidney failure

Certain boxes of Dépakine 500 mg could thus be delivered instead of boxes of Dépakine 200 mg, leading to a risk of overdose for the patient, particularly in children and patients with renal insufficiency. This problematic distribution began on March 22. The ANSM specifies that: “Patients who have been issued a box of the lot affected by this barcode defect will be contacted by their pharmacist“.

If you (or your child) are being treated with Dépakine 200 mg, gastro-resistant tablet (tube of 40 tablets, with “200 mg” written in purple), check on the box that it is not Dépakine Chrono 500 mg, film-coated, scored, sustained-release tablet (tube of 30 tablets with “chrono 500 mg” written in green).

If you have received a box of Dépakine Chrono 500 mg while you (or your child) are being treated with Dépakine 200 mg, return it to the pharmacy. Your pharmacist will check your box and issue you with a Dépakine 200 mg box.

What are the risks if I used the Dépakine Chrono 500 mg box?

Taking Dépakine chrono 500 mg may result in an overdose compared to the treatment usually taken, particularly in children and patients with renal insufficiency.

If you have taken Dépakine chrono 500 mg instead of Dépakine 200 mg, contact your doctor, particularly if you (or your child) experience digestive problems (nausea, vomiting, diarrhea, abdominal pain) or drowsiness. Do not stop your treatment without talking to your doctor.