Valproate Migraine Drugs Lead to Lower IQs in Children
On May 6, 2013 the U.S. Food and Drug Administration (FDA) published a warning that the antiseizure drug Valproate should no longer be used in pregnant women for the treatment of migraines. This safety alert was issued after a new study found that it lowered the IQ of children exposed to valproate type drugs in utero.
According to Medical News Today, sodium valproate is a prescription anticonvulsant for the treatment of
- Bipolar disorder
- Post-traumatic stress disorder (PTSD)
- Anxiety disorder
- Anorexia nervosa
The NEAD Study
The study was called the Neurodevelopmental Effects of Antiepileptic Drugs, or NEAD study. It began in 1999 and followed 300 children in the U.S. and U.K. who were born to mothers taking the antiepileptic drugs-
Cognitive Test Results
IQ assessments were preformed for children at 6-years of age who had been exposed to the antiepileptic drugs in utero. Interim cognitive tests were also done on the children at other points, including at 3-years of age.
- Average IQ scores varied between the children exposed to Valproate as apposed to other antiepileptic drugs by 8 to 11 points.
- Results of the NEAD study also indicated that periconceptional folate use helped to raise children’s mean IQ. However, the FDA cautioned that these findings were preliminary.
- Research did not confirm whether or not the timing of exposure during pregnancy was a factor. All the women in the study used the medication throughout their pregnancies.
The NEAD Study is Consistent with Previous Research
Conclusions of the study echo initial findings the FDA announced in June 2011. At that time they revised Valproate labels due to interim findings from the NEAD study on the cognitive assessments of 3-year old children exposed to the drug during pregnancy.
Results of the NEAD study also coincide with other epidemiological research of children exposed to Valproate while in the womb. These studies also indicate a measurably lower IQ score for children exposed to the drugs compared to children who were not.
Valproate Linked to other Serious Birth Defects
For a long time, Valproate has also been associated with other birth defects including neural tube defects like spina bifida.
Contact an Experienced Child Safety Recall Attorney
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