Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jun 13;3(3):357-363.
doi: 10.1002/epi4.12228. eCollection 2018 Sep.

Valproic acid utilization among girls and women in Stockholm: Impact of regulatory restrictions

Linnéa Karlsson Lind  1   2 , Joris Komen  3 , Björn Wettermark  1   4 , Mia von Euler  2   5   6 , Torbjörn Tomson  7
Affiliations

Valproic acid utilization among girls and women in Stockholm: Impact of regulatory restrictions

Linnéa Karlsson Lind et al. Epilepsia Open. .

Abstract

Objective: In November 2014, the European Medicines Agency (EMA) strengthened restrictions on the use of valproic acid in girls and women of childbearing potential. The objective of this study was to determine whether there has been a change in initiations of valproic acid treatment to females after the regulatory restrictions and to assess if such changes differed between indications (epilepsy and psychiatric disorder).

Methods: An interrupted time-series analysis was conducted using all initiations of valproic acid in Stockholm, Sweden. from January 2011 to June 2017. Female and male patients aged 0-45 years with a recorded diagnosis of epilepsy and/or a psychiatric disorder were compared.

Results: Before the EMA warning, a decline in trend of valproic acid initiations was seen in patients with epilepsy. After the warning, a significant decrease of valproic acid initiations was seen in women with a psychiatric disorder, but not in women with epilepsy.

Significance: The regulatory warning appeared to have significantly influenced valproic acid initiations in women of childbearing age with a psychiatric disorder. No effect was seen in women with epilepsy, probably because the decline had started long before.

Keywords: Epilepsy; Interrupted time series; Psychiatric disorder; Regulatory warnings; Sex differences.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Initiations of valproic acid in men and women regardless of diagnosis
Figure 2
Figure 2
Patterns of valproic acid initiations in males and females 0–45 years of age diagnosed with epilepsy from January 2011 through June 2017
Figure 3
Figure 3
Patterns of valproic acid initiations in males and females 0–45 years of age diagnosed with psychiatric disorder from January 2011 through June 2017
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Tomson T, Marson A, Boon P, et al. Valproate in the treatment of epilepsy in girls and women of childbearing potential. Epilepsia 2015;56:1006–1019. - PubMed
    1. European Medicines Agency . Amendments to be included in sections of the summary of product characteristics for valproic acid/valproate containing medicinal products, as relevant, 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/.... Accessed March 2017.
    1. Tomson T, Battino D. Teratogenic effects of antiepileptic drugs. Lancet Neurol 2012;11:803–813. - PubMed
    1. Nadebaum C, Anderson V, Vajda F, et al. The Australian brain and cognition and antiepileptic drugs study: IQ in school‐aged children exposed to sodium valproate and polytherapy. J Int Neuropsychol Soc 2011;17:133–142. - PubMed
    1. Bromley RL, Mawer G, Love J, et al. Early cognitive development in children born to women with epilepsy: a prospective report. Epilepsia 2010;51:2058–2065. - PubMed

LinkOut - more resources