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Regulatory restrictions on the use of valproate in girls and women of childbearing potential: status update

https://doi.org/10.17749/2077-8333/epi.par.con.2021.101

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Abstract

In 2019, some restrictions for use of valproic acid in women with reproductive potential by regulatory authorities and the original drug manufacturer based on the results of studies in real clinical practice were introduced. During 2019–2021, there were a further clinical data accumulation and labeling changes. The review presents a critical analysis of the changes in prescribing information and product label. There is a long lead time from the moment when safety data become known to the moment when changes are made to the medicinal product label and patient brochures. Some of the changes, including the need for high doses of folic acid to prevent neural tube defects, are debatable. Repealing the provision for mandatory archiving of informed consent forms for valproic acid use in girls and women raises legal risks. Improvements in pregnancy prevention programs and further research on the safety of valproic acid in real-world clinical settings are needed.

About the Authors

D. V. Blinov
Institute for Preventive and Social Medicine; Institute for Preventive and Social Medicine; Moscow Haass Medical Social Institute
Russian Federation

Dmitry V. Blinov – MD, PhD, MBA, Head of Medical and Scientific Affairs; Neurologist; Faculty Member, Department of Neurology, Psychiatry and Narcology

4/10 Sadovaya-Triumfalnaya Str., Moscow 127006

111 1st Uspenskoye Hwy, Moscow Region, Odintsovo District, Lapino 143081

5 bld. 1-1a 2nd Brestskaya Str., Moscow 123056

WoS ResearcherID: E-8906-2017

Scopus Author ID: 6701744871

RSCI SPIN-code: 9779-8290



E. S. Akarachkova
International Society “Stress Under Control”; Sechenov University
Russian Federation

Elena S. Akarachkova – Dr. Med. Sc., Neurologist, President

40 Musa Dzhalil Str., Moscow 115573

8/2 Trubetskaya Str., Moscow 119991

RSCI SPIN-code: 8481-7947



V. I. Tsibizova
Almazov National Medical Research Centre
Russian Federation

Valentina I. Tsibizova – MD, PhD, Department of Functional and Ultrasound Diagnostics

2 Akkuratov Str., Saint Petersburg 197341

RSCI SPIN-code: 8272-5074



D. I. Korabelnikov
Moscow Haass Medical Social Institute
Russian Federation

Daniil I. Korabelnikov – MD, PhD, Professor, Chair of Internal Diseases, General Practice, Functional Diagnostics and Infectious Diseases, Rector

5 bld. 1-1a 2nd Brestskaya Str., Moscow 123056

RSCI SPIN-code: 7380-7790



N. V. Pavlova
Yevdokimov Moscow State University of Medicine and Dentistry
Russian Federation

Nadezhda V. Pavlova – MD, PhD

20/1 Delegatskaya Str., Moscow 12747



I. V. Kukes
International Association of Clinical Pharmacologists and Pharmacists
Russian Federation

Ilya V. Kukes – MD, PhD, Clinical Pharmacologist, Immunologist, Head of Medical and Scientific Affairs

11 corp. 10 Yauzskaya Str., Moscow 109240

RSCI SPIN-code: 1166-3569



D. A. Petrenko
Sechenov University
Russian Federation

Daria A. Petrenko – 6th-year Student, International School “Medicine of the Future”

8/2 Trubetskaya Str., Moscow 119991



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For citation:


Blinov D.V., Akarachkova E.S., Tsibizova V.I., Korabelnikov D.I., Pavlova N.V., Kukes I.V., Petrenko D.A. Regulatory restrictions on the use of valproate in girls and women of childbearing potential: status update. Epilepsy and paroxysmal conditions. 2021;13(3):254-263. https://doi.org/10.17749/2077-8333/epi.par.con.2021.101

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ISSN 2077-8333 (Print)
ISSN 2311-4088 (Online)