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Depakote (generic name valproate sodium) has been commonly prescribed for seizures since 1983 and now is given to patients for migraines and bipolar disorders. In some cases, mental health professionals recommend it as an off-label (not FDA-approved) treatment for psychological diagnoses.

Effects

When prescribed for treating multiple types of seizure disorders, Depakote influences bodily chemicals associated this with condition, and has been given in combination with other seizure medications in certain cases. Since 2006, the U.S. Food and Drug Administration (FDA) has warned patients about birth defects associated with Depakote, after a study reported 20 percent of women pregnant while taking the medication gave birth to children with the following conditions:

  • Spinal bifida
  • Neural tube defects
  • Cardiac defects
  • Facial clefts
  • Cleft palate
  • Congenital anomalies
  • Hypospadias
  • Craniosyntosis
  • Limb defects
  • Cognitive issues
  • Symptoms confused with fetal alcohol syndrome

In 2009, a study published in The New England Journal of Medicine found children exposed to Depakote while in utero had IQs eight to 11 points lower than children exposed to other epileptic drugs. The Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study examined pregnant women in the U.S. and U.K. from 1999 to 2004 taking a single antiepileptic medication. The effects were observed in children 3 years of age.

Warning

On May 6, 2013, the FDA released a safety warning stating Depakote has been contraindicated for migraine prevention in pregnant women because of studies associating it with decreased IQ scores in exposed children. Healthcare professionals, in response, are advised to not prescribe valproate sodium, as well as valproic acid and divalproex sodium, for migraine headaches. The pregnancy category for Depakote has since been changed from “D,” indicating its potential benefits are acceptable in spite of the potential risks, to “X,” in which a drug’s risks far outweigh the benefits.

Legal Action

For many women, their children, and healthcare professionals, the studies and news came too late. Responsible for regularly testing drugs and informing the public of its risks, manufacturer Abbott Laboratories did not provide sufficient warnings and, as a result, had been sued by a group of women in 2012 over birth defects.

Abbott has additionally been met with legal action over its marketing practices: specifically, targeting the drug for schizophrenia and autism spectrum disorders, for which Depakote has not been approved, and promoting it to elderly patients with dementia.

Lawsuits, to hold the drug manufacturer accountable for its marketing practices and lack of warnings, have recouped the cost of medical care for a child’s long-term injuries and pain and suffering. The statute of limitations for filing a claim is 20 years.

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