Valproate and the Pregnancy Prevention Programme: exceptional circumstances

In March 2018 the European Medicines Agency endorsed new measures to avoid in utero valproate exposure. Subsequently, updated valproate regulations published by the Medicines and Healthcare products Regulatory Agency (MHRA)1 contraindicate the use of valproate medicines in girls or women of childbea...

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Bibliographic Details
Published in:British journal of general practice 2019-04, Vol.69 (681), p.166-167
Main Authors: Watkins, Lance V, Cock, Hannah R, Angus-Leppan, Heather, Shankar, Rohit
Format: Article
Language:English
Subjects:
Abnormalities, Drug-Induced - etiology
Abnormalities, Drug-Induced - prevention & control
Anticonvulsants - pharmacology
Birth control
Drug and Narcotic Control
Epilepsy
Europe
Female
Fetuses
Human exposure
Humans
Migraine
Pregnancy
Pregnancy Complications - drug therapy
Prescription drugs
Risk Adjustment - ethics
Risk Adjustment - legislation & jurisprudence
Risk Adjustment - methods
Side effects
Status Epilepticus - drug therapy
Teratogens - pharmacology
Valproic Acid - pharmacology
Womens health
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Summary:In March 2018 the European Medicines Agency endorsed new measures to avoid in utero valproate exposure. Subsequently, updated valproate regulations published by the Medicines and Healthcare products Regulatory Agency (MHRA)1 contraindicate the use of valproate medicines in girls or women of childbearing age unless they participate in the Pregnancy Prevention Programme. Participants must be fully informed of the risks of valproate use in pregnancy, sign a Risk Acknowledgement Form each year, have an annual specialist review, and adhere to a highly effective (pregnancy rate of
ISSN:0960-1643
1478-5242
DOI:10.3399/bjgp19X701897