Prevalence of valproate Syndrome in Europe from 2005 to 2014 : A registry based multi-centre study

Women with epilepsy need to continue to take anti-convulsants during their pregnancies to prevent seizures from occurring. Since the 1980’s, it has been known that the use of valproate (an anti-convulsant) in the first trimester of pregnancy is associated with an increased risk of spina bifida. Recent studies have also demonstrated increased risks of other congenital anomalies as well as a risk of cognitive impairment. Doctors in the EU are now advised not to prescribe valproate in pregnant women, in women who can become pregnant or in girls unless other treatments are ineffective or not tolerated. This study aimed to determine if there has been a reduction in the numbers of babies born with valproate syndrome in Europe from 2005 to 2014. Data from 15 European congenital anomaly registries, who are members of EUROCAT, identified 28 cases of valproate syndrome in 2.74 million births from 2005 to 2014. The prevalence of valproate syndrome in Europe significantly decreased from 0.22 per 10,000 births in 2005/6 to 0.03 per 10,000 births in 2013/14. One registry, Ille de Reunion, had the majority of cases (17). After excluding these cases there still remained a decreasing trend even though it no longer reached statistical significance due to the small number of cases. This study emphasises the continued need for European collaboration in analysing rare exposures and rare anomalies.

MORRIS Joan;  GARNE Ester;  LOANE Maria;  ADDOR Marie-Claude;  BARISIC Ingeborg;  BIANCHI Fabrizio;  GATT Miriam;  LANZONI Monica;  LYNCH Catherine;  MOKOROA CAROLLO Olatz;  NELEN Vera;  NEVILLE Amanda;  O'MAHONY Marie T.;  RANDRIANAIVO Hanitra;  RISSMANN Anke;  TUCKER David;  DE WALLE Hermien;  ZYMAK-ZAKUTNYA Natalya;  RANKIN Judith; 

2019-01-21

ELSEVIER SCIENCE BV

JRC111220

1769-7212 (online),   

https://publications.jrc.ec.europa.eu/repository/handle/JRC111220,   

10.1016/j.ejmg.2018.05.008 (online),