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Published: March 1st, 2013
The use of the epilepsy drug Depakote and similar drugs have been linked to an increased risk of birth defects and malformations, including cleft palate, spina bifida and deformed limbs and skulls.
DEPAKOTE LAWSUIT STATUS: Product liability lawyers are evaluating potential Depakote birth defect lawsuits for individuals who took valproate-based drugs during pregnancy and gave birth to a child with malformations or other problems.
MANUFACTURER: Abbot Laboratories
OVERVIEW: Depakote (valproic acid) is an anti-seizure drug approved by FDA in 1983 for the treatment of epilepsy. It belongs to a class of drugs based on valproate; which includes Depacon, Stavzor, and the first drug in the class, Depakene, which was first approved in 1978.
Valproate, or valproic acid, is an anticonvulsant and mood-stabilizing drug. In addition to epilepsy, it is often prescribed to treat bipolar disorder and depression.
DEPAKOTE BIRTH DEFECT SIDE EFFECTS: In 2006, the FDA added a “black box” warning about the potential risk of a birth defect from Depakote use during pregnancy. The warning came after a study found that 20% of pregnant mothers who gave birth while on Depakote resulted in a child with birth defects.
In May 2010, researchers found that Depakote birth defect side effects could be caused by using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child.
Researchers have linked the Depakote side effects to the following birth defects:
- Spina bifida
- Cleft palate
- Abnormal skull formation
- Malformed limbs
- Extra fingers and toes
- Urinary problems
- Holes in the heart
Spina bifida from Depakote is the most common birth defect associated with the drug. Researchers have found that pregnant women taking the drug are 12 times more likely to have a child with spinal bifida than women who are not taking it.
In December 2009, the FDA strengthened birth defect warnings on Depakote and other valproic acid drugs, telling healthcare professionals to warn all women of childbearing age taking the drugs that they could cause a wide variety of birth defects.
DEPAKOTE DEVELOPMENTAL DELAYS: A number of studies have linked Depakote use during pregnancy to developmental delays as well, including an increased risk of cognitive disability, autism and lower IQ scores.
In early 2013, two studies were published that found that Depakote use increased the risk of developmental delays, impacting memory, verbal skills and executive function. One study found an increase in the risk of autism as well, echoing the findings of a 2011 study by Danish researchers.