Depakote Pregnancy Risks Leads EMA to Recommend Restrictions

As concerns continue to mount about the link between Depakote and birth defects, European drug safety experts indicate that restrictions should be placed on use of the medication for treatment of epilepsy or bipolar disorder among women who may become pregnant. 

The European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) issued recommendations on October 10, which call for more stringent restrictions on Depakote’s active ingredient, valproate, due to the risk of malformations and developmental problems among children exposed to the drug during pregnancy.

“Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated,” the committee recommended. “Women for whom valproate is the only option after trying other treatments, should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.”

In some countries, the drug is used to treat migraines as well, and PRAC also calls for the same restrictions in those cases.

The committee found that there was a significant lack of education on the subject among women and even some doctors, and urged doctors to fully inform women of about the risks of Depakote birth defects.

The recommendations came as the result of a year-long review of the side effects of Depakote and their effects on pregnancy. PRAC found that 30% to 40% of children exposed to Depakote in the womb suffered developmental problems. These included walking and talking delays, speech and language problems and a lower IQ.

The review found that there was an 11% chance of the child suffering malformations such as neural tube and cleft palate defects.

The EMA will now look at the recommendations and adopt a final position in the near future.

Depakote Concerns in U.S.

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.

In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women using it to treat epilepsy. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.

Abbott Laboratories, the makers of Depakote, currently faces a number of Depakote birth defect lawsuits filed by families throughout the country, which allege that the drug maker failed to adequately research the medication or warn consumers and the medical community about the risks associated with using the popular medication during pregnancy.