The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2018 (PDF).
This issue advises clinicians that valproate medicines (Epilim®, Depakote®) are contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met. Materials supporting implementation of the Pregnancy Prevention Programme are being distributed. GPs are being advised that they must identify and recall all women and girls who may be of childbearing potential, provide the Patient Guide and check they have been reviewed by a specialist in the last year and are on highly effective contraception. These new measures have been reported in the general media. Valproate medicines are also now subject to more intense surveillance ("Black Triangle ▼") and therefore any suspected adverse reactions associated with valproate should be reported, including adverse pregnancy outcomes.
This issue also contains a general reminder that any healthcare professional can submit a Yellow Card if an adverse reaction is suspected. If your occupation is not available in our drop-down list, you can now select 'Other healthcare professional'.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.