A lot of Sanofi anti-epileptic drugs in the form of oral solution, including both depakine and its generic, is being recalled due to a risk of under-dosing due to a non-compliant pipette , according to the ANSM Medication Agency. Under-dosing of treatment results in "decreased effectiveness of antiepileptic treatment" and therefore carries a risk of epileptic seizures. This is the batch No. 013097 (expiry 08/2020) common drugs Depakine 200mg / ml oral solution and sodium Valproate Zentiva 200mg / ml oral solution, laboratory Sanofi-Aventis France, said the health agency Thursday in a communicated.
Free replacement box in pharmacy. The French Medicines Agency is asking patients not to stop their treatment and to return the boxes and pipettes of this lot 013097 to the pharmacy as soon as possible for a free delivery of a spare box. Patients who use the wrong pipette should "consult their doctor as soon as possible to assess the balance of their antiepileptic treatment". Pharmacists must "contact, by all means available to patients who may hold and / or have used the specialties of the lots concerned by this recall".
Underdosing. This batch recall follows a report of the presence in a box of a pipette mentioning a dosage of 300 mg / ml (dosage not marketed in France) instead of a pipette 200 mg / ml. The use of the wrong pipette resulted in underdosing in one patient. The bad pipettes are recognizable by the mention "300mg / ml" . They are the same size and color as the good ones. According to the laboratory Sanofi-Aventis France, this defect concerns only some of the 88,000 boxes of lot 013097 distributed in France between February and August 2018.