Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Aug 5, 2019

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Abbott Laboratories anti-epileptic drug, Depakote, has been linked to Spina Bifida, cleft palates, limb deformity, congenital cardiac defects, facial dysmorphism, lower I.Q.s and many other birth defects as evidenced by numerous studies and a black box warning from the U.S. Food & Drug Administration (FDA).

Studies & Black Box warning

There have been numerous studies and an FDA black box warning alerting women about the risks of using Depakote, also sold under the brand names Depakote, Depakote ER, Depakote Sprinkles, Depacon, Stavzor and generically as divalproex sodium. These drugs contain the chemical compound valproic acid (VPA), or Valproate, which is an anti-convulsant mood-stabilizing drug drug used to treat epilepsy, schizophrenia, migraine headaches, bipolar disorder and depression. Here’s an overview of each study and the FDA’s black box warning:

  • American Academy of Neurology and American Epilepsy Society. The American Academy of Neurology and American Epilepsy Society has said that pregnant women should avoid taking the drug Depakote (valproate) due to the risk of birth defects such as Spina Bifida, cleft palates, lower I.Q.s and others.
  • New England Journal of Medicine (NEJM). A 2009 study published in the New England Journal of Medicine showed that children born to mothers who took Depakote while pregnant had lower I.Q.s.
  • Hebrew University Study. A 2009 study by Hebrew University’s Hadassah Medical School and the Israeli Ministry of Health reported that exposure to valproic acid in pregnancy resulted in nearly three times as many major birth anomalies such as Spina Bifida.
  • Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study. A study published in the August 2006 issue of Neurology found that approximately 20.3% of pregnant women who took Depakote suffered serious adverse outcomes related to the birth of their children versus only 1% to 10.7% with other, similar drugs.
  • FDA Black Box Warning. The results of the NEAD study led to a Black Box warning from the FDA in October 2006, including hepatoxicity (chemical driven liver damage), teratogenicity (the capability of producing fetal malformation) and pancreatitis (the inflammation or infection of the pancreas). The FDA is currently investigating the drug’s link to autism and other developmental delays.

Depakote lawyers say that numerous Depakote lawsuits have been filed against Abbot Laboratories and that many more are expected in the future. The lawsuits generally allege that the drug company and the pharmacy which dispensed the medication should have warned consumers about the serious consequences of taking Depakote. If your child was born with birth defects, contact an attorney to discuss your situation as soon as possible as the statute of limitations in a Depakote lawsuit differ in every state.