Drug Safety Update

In January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the conditions of the pregnancy prevention programme are met.…

• Therapeutic area: Neurology and 4 others
• Published: 12 February 2020

Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminate the harms of valproate in pregnancy in view of its serious teratogenicity…

• Therapeutic area: Neurology and 5 others
• Published: 16 April 2019

…This review was initiated in the context of the known harms of valproate in pregnancy, which should only be prescribed to women of childbearing potential if there is a pregnancy prevention programme in place.…

• Therapeutic area: Neurology and 1 others
• Published: 7 January 2021

We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy. Topir…

• Therapeutic area: Neurology and 2 others
• Published: 21 July 2022

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of…

• Therapeutic area: Neurology and 2 others
• Published: 20 June 2024