FDA Safety Warning
The FDA has released warnings regarding the link between Depakote and birth defects, which include:
- Spina bifida and other neural tube defects
- Malformations of the face or head
- Malformation of cardiovascular system
- Brain defects
Depakote Pregnancy Research and Warnings
A black-box warning is the most serious warning on a drug label; issued when the agency has determined that a drug’s side effects have the potential to cause serious injuries or death. In 2006, the FDA issued a black-box warning on every Depakote prescription warning of potential birth defects. The warning followed a study published in a 2006 issue of Neurology reporting incidence of birth defects in 20 percent of women who gave birth while taking Depakote.
About Depakote Symptoms and Side-Effects
Depakote is a prescription drug developed to treat epileptic seizures and episodes of mania for those with bipolar disorder. Recently, Depakote has been prescribed for less serious conditions, such as migraine headaches. Disturbingly, children of women that take this drug during pregnancy may suffer from devastating birth defects. If proper warnings had been provided about the dangers of Depakote, women who were planning to become pregnant or those not practicing birth control, could have taken an alternative medication, one with less risks, during pregnancy.
In 2009, based on data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, the FDA required Abbott Laboratories, the manufacturer of Depakote, to strengthen the warning label, to ensure that women of child-bearing age are aware of the risk of major birth defects. These major birth defects specifically included neural tube defects, heart defects, and craniofacial birth defects.
In a 2010 study published in the New England Journal of Medicine, researchers reported an increased risk in several birth defects when Depakote was ingested during the first trimester of pregnancy. In particular, the risk for Spina Bifida increased 12 times.
Additionally, the FDA released a safety alert in May 2013 that Depakote (and valproate sodium, valproic acid, and divalproex sodium) should not be prescribed to pregnant women to treat migraine headaches. This safety alert was based on a new study that reveled that it can result in lower IQ scores in children born to women who took the drug while pregnant.Review FDA Safety Alert