Children born to mothers who took the antiepileptic drug during pregnancy sodium valproate, face a significantly increased risk - about fivefold - of developing neurodevelopmental disorders, according to a new French scientific research. Another American study found that pregnant women who take valproic acid have twice the risk of giving birth to a child with autism or ADHD (Attention Deficit Hyperactivity Disorder and Attention Deficit Hyperactivity Disorder).
The researchers, led by Dr. Rosemary Dre-Spira of French National Agency for the Safety of Medicines (ANSM), who made the relevant publication in the journal «Scientific Reports», they analysed medical records for about 1.72 million children. They found that 11,549 mothers had used an anti-epileptic drug during pregnancy, while 15,458 children (0.9% of the total) were later diagnosed with a neurodevelopmental disorder.
Sodium valproate seemed to pose the biggest problem, as 50 of the 991 children (5%) whose pregnant mothers had taken this drug for epilepsy were later diagnosed with a neurodevelopmental disorder, compared with only 0.9% among children whose mothers had not taken antiepileptic drugs during pregnancy.
Children who were exposed to sodium valproate as fetuses before birth were 5.1 times more likely to have mental retardation, 4.7 times more likely to have learning, language and motor difficulties, and 4.7 times more likely to have autism spectrum disorders.
The risk was not increased if the pregnant woman took the antiepileptic drug only in the first trimester of pregnancy, and was lower the lower the dose of the drug given to the mother.
Children born to mothers who were taking three other antiepileptic drugs during pregnancy (lamotrigine, carbamazepine and pregabalin), had respectively 1.6 times, 1.9 times and 1.5 times higher risk of subsequent neurodevelopmental disorders. No increased risk was found for some other antiepileptic drugs (clonazepam, gabapentin, levetiracetam, oxycarbazepine).
In the second study, the researchers, led by Dr. Brian D'Onofrio of Indiana University in Bloomington, who published the paper in the journal ’Neurology» of American Academy of Neurology, analysed data on 14,614 children born to mothers with epilepsy, of whom 23% were taking an antiepileptic drug in the first trimester of pregnancy. The most common drugs were carbamazepine (10% of pregnant women), lamotrigine (7%) and valproic acid (5%).
The study showed that pregnant women who took valproic acid in the first trimester of pregnancy had 2.3 times the risk of giving birth to a child with autism, as well as 1.7 times the risk of giving birth to a child diagnosed with ADHD later on. On the other hand, the study found no increased risk of autism or ADHD for children whose pregnant mothers were taking the other two anti-epilepsy drugs (carbamazepine and lamotrigine).
«Our findings add to those of other studies showing that some antiepileptic drugs may be safer than others during pregnancy. Women taking antiepileptic treatment, particularly with valproic acid, should weigh the potential risks to the fetus,» said D'Onofrio.
