Recall of a batch of an antiepileptic drug due to risk of overdose

Recall of a batch of an antiepileptic drug due to

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  • Published on 11/29/2020

    1 min read

    A batch of Micropakine, an antiepileptic drug, is being recalled due to a risk of overdose, linked to taking overfilled sachets, which can result in drowsiness or lethargy, the report said on Friday. Medicines Agency (ANSM).

    This is batch n ° DM0059 of Micropakine LP 500mg with an expiration date of March 2022 and marketed in boxes of 30 sachets.

    The recall of this drug from the Sanofi-Aventis France laboratory follows the discovery by patients in two boxes, at the same time, of empty sachets and sachets overfilled with sodium valproate granules – the same active substance as in the Dépakine, at the heart of a health scandal, which should be avoided during pregnancy.

    These anomalies were confirmed by investigations, notes the health agency.

    Taking this medication with an overfilled sachet can lead to an overdose of valproate in the patient, underlines the ANSM.

    The patients concerned must therefore return the boxes of the batch to their pharmacy as soon as possible for a free exchange, so as not to interrupt their treatment. If the patient cannot get to the pharmacy, he should contact his pharmacist or attending physician.

    Sanofi-Aventis France, in agreement with the ANSM, has also asked dispensing pharmacists and pharmacies in healthcare establishments, to contact, by all the means at their disposal, patients likely to have and / or have used the specialty of the batch concerned by this recall.

    The weight of the double-filled sachets corresponds to the weight of the Micropakine LP 1000mg sachets.

    Sodium valproate overdose is manifested by drowsiness or lethargy, adds the ANSM. She advises patients taking this granulated treatment to “contact their doctor as soon as possible if they have any unusual symptoms.”

    To date, no case of adverse effect related to this defect has been reported to the ANSM.“, specifies the latter.