Sodium valproate |
Formulary
|
M/R tablets In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:
National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2 |
MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception |
|
Valproic Acid Depakote® |
Formulary
|
E/C tablets 250mg, 500mg In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:
National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2 |
MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception |
|