Impact of regulatory safety notices on valproate prescribing and pregnancy outcome among women of child-bearing potential in Scotland: a population-based cohort study

Stuart Mctaggart; Gavin Maccoll; Karen Gronkowski; Rachael Wood; John Paul Leach; Marion Bennie

doi:10.1136/bmjopen-2021-058312

Impact of regulatory safety notices on valproate prescribing and pregnancy outcome among women of child-bearing potential in Scotland: a population-based cohort study

Stuart Mctaggart, Gavin Maccoll, Karen Gronkowski, Rachael Wood, John Paul Leach, Marion Bennie

Deanery of Clinical Sciences

Research output: Contribution to journal › Article › peer-review

Original language	English
Pages (from-to)	e058312
Journal	BMJ Open
Volume	12
Issue number	4
Early online date	13 Apr 2022
DOIs	https://doi.org/10.1136/bmjopen-2021-058312
Publication status	E-pub ahead of print - 13 Apr 2022

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10.1136/bmjopen-2021-058312

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https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2021-058312

Cite this

@article{712e5d8e56a94010af8b8bf2846a2cf0,

title = "Impact of regulatory safety notices on valproate prescribing and pregnancy outcome among women of child-bearing potential in Scotland: a population-based cohort study",

author = "Stuart Mctaggart and Gavin Maccoll and Karen Gronkowski and Rachael Wood and Leach, {John Paul} and Marion Bennie",

note = "Funding Information: Contributors MB, SM and GM were responsible for the study design and SM, GM and KG were responsible for identifying data sources, obtaining data permissions and extracting and analysing the data. RW provided expert advice on the use and interpretation of pregnancy-related data and JPL provided clinical expertise on the use of sodium valproate. SM authored the manuscript and all other authors contributed to its review and refinement. MB is the guarantor for this study and is the corresponding author. Funding This study was supported by the Chief Medical and Chief Pharmaceutical Officers of the Scottish Government and by the Medicines and Healthcare products Regulatory Agency. Competing interests In the last 10 years JPL has received speaker{\textquoteright}s fees and Advisory Board honoraria from UCB Pharma, EISAI, Desitin, GlaxoSmithKline, GW Pharmaceuticals, Biogen and Arvelle. There has been an award of an unrestricted Independent Investigator Award from UCB in 2015 to fund a research fellow. SM, GM, KG, RW and MB have no competing interests to declare. Publisher Copyright: {\textcopyright} 2022 BMJ Publishing Group. All rights reserved.",

year = "2022",

month = apr,

day = "13",

doi = "10.1136/bmjopen-2021-058312",

language = "English",

volume = "12",

pages = "e058312",

journal = "BMJ Open",

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T1 - Impact of regulatory safety notices on valproate prescribing and pregnancy outcome among women of child-bearing potential in Scotland: a population-based cohort study

AU - Mctaggart, Stuart

AU - Maccoll, Gavin

AU - Gronkowski, Karen

AU - Wood, Rachael

AU - Leach, John Paul

AU - Bennie, Marion

N1 - Funding Information: Contributors MB, SM and GM were responsible for the study design and SM, GM and KG were responsible for identifying data sources, obtaining data permissions and extracting and analysing the data. RW provided expert advice on the use and interpretation of pregnancy-related data and JPL provided clinical expertise on the use of sodium valproate. SM authored the manuscript and all other authors contributed to its review and refinement. MB is the guarantor for this study and is the corresponding author. Funding This study was supported by the Chief Medical and Chief Pharmaceutical Officers of the Scottish Government and by the Medicines and Healthcare products Regulatory Agency. Competing interests In the last 10 years JPL has received speaker’s fees and Advisory Board honoraria from UCB Pharma, EISAI, Desitin, GlaxoSmithKline, GW Pharmaceuticals, Biogen and Arvelle. There has been an award of an unrestricted Independent Investigator Award from UCB in 2015 to fund a research fellow. SM, GM, KG, RW and MB have no competing interests to declare. Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved.

PY - 2022/4/13

Y1 - 2022/4/13

U2 - 10.1136/bmjopen-2021-058312

DO - 10.1136/bmjopen-2021-058312

M3 - Article

VL - 12

SP - e058312

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

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ER -