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Depakote and Birth Defects

Shot of a sleeping baby girl with a cleft palate being held by her mother

Sometimes a medication is known to cause birth defects or harm to infants, but a doctor will still prescribe it to a pregnant or nursing mother. That is often the case with Depakote, also known as valproic acid or valproic semisodium. Reliable studies have uncovered a significant link between Depakote and birth defects. Why, then, would doctors continue to prescribe it to women who are, or who may become, pregnant? Often, because they believe the benefit of the medication to the mother outweighs the risk of harm to the child. However, the person with the ultimate right to decide whether or not to accept that risk is the patient herself, so a doctor should fully inform patients of the connection between Depakote and birth defects.

What is Depakote Prescribed For? 

Since it was first introduced by Abbott Laboratories in 1983, Depakote has been commonly prescribed for the treatment of seizures, bipolar disorder, and migraines. The appropriate dosage and method of administration depends on the condition being treated. Tens of millions of Americans take Depakote or its generic versions for treatments of these conditions.

What Birth Defects Can Depakote Cause? 

The U.S. Food and Drug Administration first issued a warning about Depakote for pregnant women in 2007, indicating that the use of the medication had been associated with an increased risk of serious birth defects. As a result, Depakote was categorized as a Class D drug with respect to pregnancy. This means that studies showed adverse reaction data indicating positive evidence of human fetal risk. While studies cannot be conducted on human babies for ethical reasons, a significant number of babies whose mothers took Depakote had birth defects including:

  • Spina bifida
  • Lower IQ
  • Congenital heart defect (Atrial Septal Defect or ASD, otherwise known as “a hole in the heart”)
  • Cleft palate or cleft lip
  • Anencephaly (absence of a major part of the brain, skull, and scalp)
  • Hypospadias (opening of the urethra is on the underside of the penis instead of at the tip)
  • Polydactyly (more than five digits on a hand or foot)
  • Craniosynostosis (one or more cranial sutures fuses too early, affecting brain and skull growth)

The connection between Depakote and many of these conditions is strong. For instance, the infant of a mother who took Depakote during her pregnancy is 12.5 times more likely to have spina bifida than a child who did not. Infants exposed to Depakote during pregnancy are five times more likely to develop cleft lip or cleft palate, and 2.5 times more likely to develop an atrial septal defect.

Given the extremely serious nature of neural tube defects and other issues associated with Depakote use during pregnancy, a woman should make the decision to take or continue taking the drug only after being fully informed of the risks and benefits. Children born with birth defects associated with their mother’s Depakote use may suffer from lifelong disabilities, and may require costly surgery, treatments, and therapy. 

A mother’s use of Depakote during breastfeeding may also have an adverse effect on her child. Depakote not only enters the mother’s bloodstream, but is also present in her breastmilk. The National Institutes of Health published a report stating that infants may experience drowsiness and sedation while nursing. When the mothers discontinued Depakote use, these symptoms went away. As with infants born to mothers who used Depakote during pregnancy, not all babies exposed to Depakote through breastfeeding experienced symptoms, but the risk is there. 

Liability for Birth Defects From Depakote

You may, after a full review of the risks and careful consultation with your doctor, decide that it is worth taking Depakote while pregnant. However, if your doctor failed to inform you of the risks before you consented to Depakote use during pregnancy, he or she may have committed medical malpractice. Failure to obtain informed consent for treatment from a patient may be medical malpractice if the patient is harmed as a result. You may be entitled to compensation to help pay for your child’s medical needs. Speak to an experienced Oregon medical malpractice attorney about your options. Remember that the time to file a claim is limited, so don’t delay.

If you have questions about Depakote and birth defects, or feel that your doctor did not adequately inform you of the risks of taking Depakote during pregnancy and breastfeeding, we invite you to contact Huegli Fraser to schedule a complimentary consultation. We will listen to your story and help you evaluate whether you have a claim worth pursuing.

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Categories: Medical Malpractice

Blog Disclaimer

The information in this blog post is provided for informational purposes only and is not intended to be legal advice. You should not make a decision whether or not to contact a qualified medical malpractice attorney based upon the information in this blog post. No attorney-client relationship is formed nor should any such relationship be implied. If you require legal advice, please consult with a competent medical malpractice attorney licensed to practice in your jurisdiction.

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