Is the Medicines and Healthcare products Regulator Agency (MHRA) guidance on sodium valproate acceptable to women of childbearing age?

Ian Morrison (Lead / Corresponding author), Hannah Cork, Pauline Smith, Charlene Campbell, Megan McTiernan, Kathleen White

    Research output: Contribution to journalArticle

    Abstract

    Background: The UK Medicines and Healthcare products Regulatory Agency (MHRA) published guidelines restricting the use of sodium valproate in women of childbearing age unless they consented to the pregnancy prevention programme (PPP), receiving counselling by an epilepsy specialist, or meeting exclusion criteria.

    Methods: We contacted every woman of childbearing age on valproate for epilepsy in NHS Tayside (122).

    Results: Seventeen out of 122 (13.9%) responded to the initial invitation to attend, and 25 out of 122 (20.4%) responded to a letter sent to their GP. Twenty-five attended, 21 completed a consent form, seven switched to another drug and three attended to express dissatisfaction with the MHRA guidance. There were 53 patients identified with learning difficulties. Consent was only taken from three patients, with carers declining to sign consent because the patient was not sexually active.

    Conclusion: Our study suggests that patients and carers do not wish to stop valproate or engage in PPP despite being made aware of MHRA guidance.

    Original languageEnglish
    Pages (from-to)114-117
    Number of pages4
    JournalJournal of the Royal College of Physicians of Edinburgh
    Volume50
    Issue number2
    DOIs
    Publication statusPublished - Jun 2020

    Keywords

    • sodium valproate
    • Pregnancy
    • MHRA
    • PPP teratogenicity
    • Sodium valproate

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