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THE ESSENTIAL
- Lot No. DM0059 is being withdrawn from the market due to the risk of overdose, which can cause drowsiness or lethargy.
On Friday 27 November, the National Agency for Medicines and Health Products Safety (ANSM) announced the withdrawal of a batch of the antiepileptic drug Micropakine marketed by the Sanofi-Aventis France laboratory.
According to the health authority, the patients discovered “in two boxes at the same time, empty sachets and sachets too full of valproate granules”. The affected lot is batch DM0059 of Micropakine LP 500 mg, extended release granules in sachets. The expiry date of the lot is March 2022, which is sold in boxes of 30 sachets.
Risk of overdose
According to the ANSM, the intake of double-filled sachets, which correspond to the weight of the 1000 mg Micropakine LP sachets, can “lead to an overdose of valproate, resulting in drowsiness or lethargy.”
If for the moment “no case of negative effect related to this defect has been reported”, ANSM, in agreement with Sanofi-Aventis France, asks the affected patients to return the boxes as soon as possible. of the lot in their pharmacy. They can make a free exchange so as not to interrupt their processing. If it is impossible to go to the pharmacy, patients should contact their pharmacy or their doctor.
Micropakine’s manufacturer, the Sanofi-Aventis France laboratory, in agreement with the ANSM, has also asked pharmacists to contact, by all means at their disposal, patients who may have and / or have used the specialty. of the lot affected by this recall.
The Dépakine scandal in memory
This recall of a batch of Micropakine comes after the Dépakine health scandal, also marketed by Sanofi. Prescribed to combat epilepsy or bipolar disorders, this sodium valproate drug has been shown to be the cause of malformations or neuro-developmental disorders in children exposed during pregnancy. Now prohibited to pregnant women, women or adolescents of childbearing age, Dépakine is believed to have caused 2,150 to 4,100 severe congenital malformations since it was placed on the market according to an ANS assessment dating back to 2017. Children exposed in utero have four to five times more likely to develop mental and behavioral disorders. In all, 16,000 to 30,000 children are believed to be affected.
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