Risk of Birth Defects Reportedly Doubles With Depakote Use

Seattle, WAIf you have never heard of fetal valproate syndrome, you are probably not alone. But for some women who took Depakote while pregnant, Depakote birth defects are a serious concern. Infants exposed to the medication are reportedly at an increased risk of suffering Depakote side effects, including serious health problems.

Fetal valproate syndrome refers to several congenital birth defects that have been linked to exposure to valproic acid during the first trimester. Valproic acid, used in anti-seizure medications such as Depakote and Divalproex, has been linked to several birth defects in infants exposed to the medications prior to birth. Those birth defects reportedly include spina bifida, facial deformities and congenital heart defects such as aortic stenosis. Lower IQ scores have also been linked to fetal exposure to valproic acid.

Additional adverse effects from valproic acid may include withdrawal symptoms, autistic characteristics and developmental delays.

According to the Office of Rare Diseases Research, fetal exposure to valproic acid is linked to two to three times greater risk of birth defects. Unfortunately, there is no treatment for fetal valproate syndrome. Each symptom or birth defect might be managed separately, depending on the nature and severity of the defect. Some development delays, such as difficulty with speech and motor delays, may be helped by early intervention.

Families who have children born with fetal valproate syndrome could face high medical costs associated with treatment. Maria S. (real name withheld) writes that her family took out a second mortgage to pay for therapy after both sons were born with fetal valproate syndrome. She notes that it is a hardship to take care of two special needs children and work enough to afford therapy.

Valproic acid is used to prevent seizures in patients with epilepsy and to prevent manic episodes associated with bipolar disorder. Studies suggest that maternal use of Depakote while pregnant can have serious consequences for a newborn. Although there are risks to a pregnant woman having uncontrolled seizures, in some cases Depakote has been prescribed for the prevention of migraine headaches. In such cases, the benefits of taking the medication may not outweigh the risks.

In May, Abbott Laboratories said it would pay $1.6 billion to settle claims it illegally marketed Depakote for off-label use such as to treat schizophrenia, autism and dementia.

Depakote is classed in Food and Drug Administration (FDA) pregnancy category D because of the possibility of serious birth defects.