Depakote Pregnancy Risk Leads To New FDA Restrictions

According to a new warning issued by federal drug regulators, pregnant women should not use certain epilepsy drugs to treat migraines, due to a potential risk that drugs like Depakote may cause I.Q. problems for children.  

On May 6, the FDA issued a drug safety communication, indicating that Depakote and other valproate-based drugs carry potential pregnancy risks, which could result in decreased IQ scores among children whose mothers took the medications while pregnant.

The FDA has stopped short of contraindicating Depakote pregnancy use and limited the contraindication to women using the drug to prevent migraines. However, serious concerns exist about the risk of problems for unborn children exposed to Depakote, Depacon and other valproate-based medications.

A number of recent studies have highlighted the risk of Depakote birth defects. After analyzing the available data, the FDA has changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines. In addition to Depakote and Depacon, other drugs that are affected by the warning include Depakene, Stavzor and generic equivalents.

A Class D classification means that a drug’s benefits may be acceptable despite known potential risks to pregnant women. A Class X designation means that the risks of a drug outweigh the benefits for pregnant women. However, the FDA still considers the side effects to be an acceptable risk for the treatment of epilepsy and manic episodes associated with bipolar disorder, but not migraines.

Depakote Birth Defects and Developmental Delays

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy risks have been associated with the development of severe birth defects and malformations, including spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.

Earlier this year, a study published by the Journal of Neurology, Neurosurgery and Psychiatry suggested that children born to women who used Depakote during pregnancy have a greater risk of experiencing potentially severe developmental delays, including reduced I.Q. and autism.

According to another study published in the Journal of the American Medical Association (JAMA) in April 2013, researchers linked a three times increase in the risk of autism with Depakote pregnancy use.

An increasing number of parents are now pursuing a Depakote lawsuit after the mother took the epilepsy drug and gave birth to children who may have suffered developmental delay or birth defects. The complaints allege that the manufacturer failed to adequately research the medication or warn consumers about the risks associated with becoming pregnant, placing their desire for profits before patients safety.