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FDA Warning: Depakote May Cause Serious Birth Defects

Published on May 24, 2013 at 8:00 am in Dangerous Drugs.

Women who are pregnant or who may become pregnant should consider their treatment options before accepting a prescription for Depakote, a branded version of valporic acid made by Abbott Laboratories in the United States. Studies show that the drug increases the risk of birth defects. It has also been linked to lower IQs in the children of mothers who took the drug while pregnant.

What Does Depakote Treat?

Doctors claim that Depakote is an effective treatment for several problems, including:

  • Migraines
  • Bipolar disorder
  • Epilepsy

Some researchers also believe that the drug may play a role in treating cancer and HIV.

That makes Depakote a potentially useful drug. Unfortunately, the side effects are significant for pregnant women and their babies.

Research Shows Concerning Side Effects

A recent study published in the Journal of Neurology, Neurosurgery & Psychiatry shows that the children of epileptic women who took Depakote while pregnant had higher instances of low IQ and autism. Not every child in the study had the same response to Depakote, but there was a statistically significant increase.

A lawsuit filed in Illinois also maintains that the drug causes serious birth defects, including heart defects, neural tube defects, and spina bifida, a condition that can cause the spinal cord to protrude through the bones in the spine. The lawsuit points to Scandinavian research showing that Depakote can cause malformations in the bones and heart of children whose mothers took the drug while pregnant.

Even the FDA has warned against pregnant women taking the drug. Previously, Depakote was listed as a Category D drug. That means the FDA believed the drug had benefits that outweighed its dangers. Recently, the FDA changed Depakote’s classification to a Category X drug. This classification means that the risks outweigh potential benefits.

The FDA recommends that women of child-bearing age avoid the drug or take it in combination with birth control pills that will prevent pregnancy.