The National Agency for the Safety of Medicines and Health Products (ANSM) has just announced in a press release the reminder this Thursday, January 17 of a common batch of oral solutions of Depakine 200mg / ml and its credits Zentiva sodium valproate 200mg / ml.
This decision follows the discovery in a box of a pipette intended for a dosage of 300 mg / ml, not marketed in France, instead of a 200 mg / ml pipette. Using the wrong pipette resulted in under-dosage in a patient.
Risk of under-dosage
The under-dosage of these antiepileptic drugs, from the Sanofi-Aventis France laboratory, results in “A decrease in the effectiveness of antiepileptic treatment”, and thus increases the risk of epileptic seizures, notes the ANSM in its press release. The agency asks patients to do not stop their treatment, but to bring back to their pharmacists the boxes and pipettes of the lot n ° 013097, with an expiration date of 08/2020. They will receive a new box from another batch free of charge.
Patients who have used the wrong pipettes, recognizable by the mention “300 mg / ml”, are invited to ” consult their doctor as soon as possible to assess the balance of their antiepileptic treatment “. But according to the laboratory, this defect would only concern a few of the 88,000 boxes of batch n ° 013097 distributed in France between February and August 2018.
⚠️Batch recall #DEPAKINE and #Valproate sodium Zentiva in oral solution 200mg / ml.
Recognize the non-compliant pipette:
It is marked “300mg / ml” instead of “200mg / ml”▶ ️ All information in the press release: https://t.co/wKgXvfCtS8pic.twitter.com/MpWzYsuVpp
– ANSM (@ansm) January 17, 2019
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