Since its first approval in 1983 for seizures, Depakote has been approved to treat various conditions. However, numerous studies conducted over the years have shown that women who take Depakote during pregnancy may have children that suffer from severe birth defects. Unfortunately, the drug’s labels may not have properly informed women of the risks.
Depakote (valproic acid) is an antiepileptic drug that is also known as sodium valproate and divalproex sodium. It is similar to Depakene, which was approved for seizures in 1978. However, Depakote has an enteric coating to help reduce the gastrointestinal effects of the drug. Depakote was approved as follows:
- Seizures (1983)
- Bipolar disorder (1995)
- Migraines (1996)
- Extended Release version (2000)
- Extended Release version and migraines (2005)
- Generic version (2008)
Reports of a link between valproic acid and birth defects date back to 1980. Other studies followed, such as a report that estimated a 20-fold increased risk of spina bifida following in utero valproate exposure. Although use of valproic acid during pregnancy is most often associated with neural tube defects, other birth complications can include the following:
- Cleft palates
- Cardiac defects
- Facial clefts
- Metopic craniosynostosis
- Limb defects
- Abnormal fingers and toes
- Facial features such as small nose, depressed nasal bridge, thin upper lip, wide-set eyes, etc.
The complications listed above are symptoms of Fetal Valproate Syndrome, which the American Journal of Medicine studied in 1984. Over the years, researchers have continued studying the effects of valproic acid use during pregnancy. For instance, one study found a four-fold increase in congenital malformations among infants who were exposed to valproic acid compared to those who were exposed to other antiepileptic drugs.
Additionally, researchers have found a link between prenatal valproic acid use and neurodevelopmental disorders in children. According to one study, “the risk of neurodevelopmental disorders was higher in children exposed to valproate monotherapy compared with control children,” and “autism spectrum disorder was the most frequent diagnosis.”
In 2009, the New England Journal of Medicine published a study that followed epileptic pregnant women from 1999 to 2004 that took one of four anti-epileptic drugs: carbamazepine, lamotrigine, phenytoin, or valproate. Children exposed to Depakote in utero were found to have significantly lower IQ levels at age three than children exposed to other anti-epileptic drugs. The authors concluded that “[t]he present results, together with other data, suggest that valproate should not be used as a first-line antiepileptic drug in pregnant women or—since data indicate that half of pregnancies are unplanned—in women of childbearing potential.”
In 2006, the FDA issued a Black Box warning for Depakote stating that valproic acid has a higher risk level than other antiepileptic drugs and can produce birth defects.
Several issues have been identified with the Depakote label over time, including:
- Pre-2006: No warning of increased birth defects compared to other drugs.
- Pre-2010: No reference to cognitive, autism, or autism-spectrum disorders.
- Pre-2011: No warning of increased risk of cognitive impairment or neurobehavioral issues.
- Pre-2013: No warning of Pregnancy Category X for migraine and no warning of secondary therapy status for epilepsy and bipolar disorder.
If you believe your child has suffered birth defects due to the negligence of pharmaceutical companies, the attorneys at Newsome Melton LLP can help you seek the compensation—and justice—that and your family deserve.