Depakote (Valproic Acid) Linked to Serious Birth Defects
By Anne Bucher
Valproic acid, sold under the brand name Depakote, is an anticonvulsant medication used to treat seizures. It also functions as a mood stabilizer. Depakote has been approved by the U.S. Food & Drug Administration (FDA) to treat manic or mixed episodes. The drug, manufactured by Abbott Pharmaceuticals, was initially approved in 1983 to treat seizures in adults and children over the age of 10. Decades later, it is now linked to a number of birth defects, including spina bifida and autism.
Women who suffer from seizure disorders often require the use of anti-seizure medication to regulate their symptoms. They face a difficult dilemma when they become pregnant, because medications often can negatively impact the fetus. An expectant mother and her physician must carefully weigh the risks associated with taking seizure medication during pregnancy. While the medication may harm the fetus, seizures pose a risk to both the mother and the unborn child.
Depakote Birth Defects
Studies have shown that the risk of babies being born with neural tube defects to mothers who took valproic acid during the first trimester of pregnancy is substantially higher than babies born to mothers who did not receive the treatment. In the United States, approximately one out of every 1,500 babies will be born with a neural tube defect. One out of 20 babies who have been exposed to valproic acid during the first trimester are born with neural tube defects.
In 2009, the FDA issued a warning to health care professionals about the increased risk of Depakote birth defects in babies exposed to valproic acid during pregnancy, especially during the first trimester. The FDA’s warning also included a strong recommendation to doctors to avoid prescribing valproic acid to women of childbearing age unless it was essential to their treatment.
Other birth defects associated with Depakote include:
- Spina bifida
- Autism
- Reduced IQ
- Cleft palate
- Hand malformations
- Hyspospadia
- Heart defects
- Undescended testes
- Dysplastic ribs
- Impaired cognitive development
- Fetal death
If you become pregnant while taking Depakote, immediately contact your physician. Do not stop taking the medication without first discussing the risks with your doctor.
Abbott’s Legal Troubles
In 2012, Abbott reached a $1.6 billion Depakote settlement with U.S. federal and state authorities. The government accused Abbott Laboratories of marketing Depakote for off-label uses that were not approved by the FDA. The U.S. Justice Department issued a statement claiming that Abbott illegally marketed Depakote for uses that had not been approved by the FDA, including the treatment of dementia, schizophrenia and autism. Although doctors are allowed to make off-label prescriptions for their patients, drug companies are prohibited from marketing their products for unapproved purposes.
Dozens of women have filed Depakote birth defect lawsuits against Abbott after their children were born with serious problems. Plaintiffs in these lawsuits accuse Abbott of negligence in the manufacturing and distribution of Depakote. They are seeking compensation for their past and future medical costs, court costs and loss of income. As more women whose children have suffered Depakote birth defects come forward, the makers of the drug will have to take notice.
If your child has suffered any birth defects that could be associated with the use of Depakote during pregnancy, contact a Depakote lawyer immediately. You may be able to join a class action lawsuit or individual Depakote injury lawsuit. Submit information about your situation on the Depakote Class Action Lawsuit Investigation page to have your case evaluated by a Depakote lawyer, free of charge.
Updated April 3rd, 2013
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3 thoughts onDepakote (Valproic Acid) Linked to Serious Birth Defects
My grandson who is expected in December 2025 has a bilateral cleft. My daughter who is bipolar and autistic was prescribed depakote with not mention of birth defects. We need help with this. my daughter is not working trying to get disability for her medical conditions, on top of having a newborn coming with bilateral cleft lip and hard pallet.
My son who is mentally handicapped was on Depakote since 1996 for seizures,March 2012 he went into a grandmal seizure and had to be put into a induced coma. The Depakote gave him hyper ammiona, His ammonia level was well over 300, He has recovered about 75% of what he was before the seizure. I looked this medication up and studies on it and it seem studies show the drug has a history of causing Hyperammiona, He is now on other medication. I call the maker of this drug the morning of his seizure and talked to a lady that the company put me on the phone with, I told the Lady my son was acting very foggy and doing strange things and asked if the Depakote could cause this and she assured me it wasnt the Depakote, that night he went into the seizure. I feel the public should know about these studies and this medicine can cause seizures.