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On 12 December 2022, as a result of growing concerns about safety, the UK’s Medicines for Healthcare products Regulatory Authority (MHRA) announced proposed changes to the regulation of valproate,1 based on recommendations from the Commission on Safety of Human Medicines. These changes will have a significant impact on valproate prescribing to males as well as females. It will be interesting to see how and when other regulatory authorities, including the European Medicines Agency and the United States’ Federal Drug Administration, will follow.
The risks associated with in utero exposure to valproate (around 10% risk of major malformation2 and 30%–40% risk of cognitive delay3) have been known for some time, and a pregnancy prevention programme for women is currently in place across Europe, which requires annual review, counselling and sign off by both clinician and patient of a paper risk acknowledgement form. The primary concern is that despite the pregnancy prevention scheme, pregnancies continue to occur with women highlighting that they have not been counselled about the risk of valproate in pregnancy. The MHRA estimates that in the UK, there were 17 valproate exposed pregnancies in the 6 months up to March 2022, although it is not clear how many had been counselled about valproate risks, down from 68 In …
Contributors TM is the sole author.
Funding TM is a National Institute for Health Research (NIHR) senior investigator and also part funded by NIHR ARC North West Coast.
Disclaimer The views expressed in this article are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care.
Competing interests TM has given a lecture at a meeting sponsored by Sanofi, honorarium paid to University of Liverpool.
Provenance and peer review Commissioned; internally peer reviewed.
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