Update information

Update information

February 2020: We amended recommendations on anticonvulsants for mental health problems in line with the MHRA guidance on valproate use by women and girls. The MHRA states that valproate must not be used in women and girls of childbearing potential (including young girls who are likely to need treatment into their childbearing years), unless other options are unsuitable and the pregnancy prevention programme is in place. We amended recommendations by moving cautions and links to the MHRA's latest advice on valproate into the recommendations.

Medicines containing valproate taken in pregnancy can cause malformations in 11% of babies and developmental disorders in 30–40% of children after birth. Valproate treatment must not be used in girls and women including in young girls below the age of puberty, unless alternative treatments are not suitable and unless the terms of the pregnancy prevention programme are met. This programme includes: assessment of patients for the potential of becoming pregnant; pregnancy tests; counselling patients about the risks of valproate treatment; explaining the need for effective contraception throughout treatment; regular (at least annual) reviews of treatment by a specialist, and completion of a risk acknowledgement form. In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation. See the MHRA toolkit to ensure female patients are better informed about the risks of taking valproate during pregnancy.

August 2017: Links were added to recommendations 1.2.3, 1.4.27, 1.4.28 and 1.4.29 to the MHRA toolkit on the risks of valproate medicines in female patients. A crosslink in recommendation 1.8.23 was updated to link to the NICE guideline on violence and aggression. We added links to recommendations 1.4.17 and 1.9.9 advising people that the UK Drugs in Lactation Advisory Service is available as an additional resource when seeking advice about specific drugs.

December 2014: New recommendations were added after a review of the evidence. These recommendations are marked as [2014]. Recommendations are marked as [2007] when the evidence was last reviewed in 2007.

Minor changes since publication

April 2022: We added a link to NICE's guideline on medicines associated with dependence or withdrawal symptoms in the sections on TCAs, SSRIs, (S)NRIs and interventions for depression and anxiety disorders.

May 2021: We linked to the updated MHRA safety advice on antiepileptic drugs in pregnancy in recommendations 1.2.2, 1.4.31 and 1.4.32.

February 2021: In recommendation 1.4.16 we highlighted the MHRA drug safety update about a small increased risk of postpartum haemorrhage with SSRI and SNRI antidepressant medicines when used in the month before delivery.

September 2016: The link in recommendation 1.4.25 has been updated.

June 2015: Corrected timescales for GAD-2 in recommendation 1.5.4.

ISBN: 978-1-4731-0875-2

  • National Institute for Health and Care Excellence (NICE)