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module menu icon Medicines causing birth defects or issues in pregnancy

11
The percentage of babies born with malformations caused by valproate taken during pregnancy

 

Valproate (Epilim; Depakote) must no longer be used in women or girls of childbearing potential unless a pregnancy prevention programme is in place and there is no alternative medicine available. Medicines containing valproate taken during pregnancy can cause malformations in 11 per cent of babies and developmental disorders in 30-40 per cent of children after birth.

Women and girls must be fully informed of the risks and the need to avoid exposure to valproate medicines in pregnancy. GPs should have contacted all patients and provided a patient guide in addition to ensuring they have seen a specialist in the last year and are on highly effective contraception. Specialists will need to re-evaluate treatments as necessary ensuring the patient has signed a risk acknowledgement form.

Pharmacists must ensure:

  • Valproate medicines are dispensed in whole packs whenever possible
  • A warning label is on the carton (this can be a sticker) when dispensing to females of childbearing potential
  • A patient card has been provided detailing the risks.
    Pregnancy risk and the need for contraception must be discussed when dispensing valproate medicines and the patient should be asked whether she has received a patient guide from her GP.

NICE has updated guidelines relevant to valproate medicines to reflect the regulatory changes.