Risks of Depakote Use in Pregnancy Lead to Stronger Warnings in UK

United Kingdom health officials are urging doctors to provide better warnings for women about the risk of becoming pregnant on Depakote, an epilepsy drug that has been linked to an increased risk of developmental disorders and birth defects. 

The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a press release on January 21, calling for healthcare professionals to provide women with better information about the risk of developmental disorders from side effects of Depakote, as well-known risks of birth defects. All drugs in the U.K. that contain Depakote’s active ingredient, valproate, will have updated label warnings.

“The warnings on the risks of valproate in pregnancy have been further strengthened because we want to ensure that medical professionals inform women and girls of the latest information about the risks of developmental disorders in children exposed to valproate during pregnancy, in addition to the already well-known risks of birth defects,” Dr. June Raine, director of MHRA’s Vigilance and Risk Management of Medicines Division said in the press release. “If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.”

The MHRA determined that out of 35,000 women prescribed Depakote or similar drugs, about 375 become pregnant per year.

The warning follows a review last year by European healthcare regulators which called for more stringent restrictions on valproate in the European Union.

European regulators 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. Regulators 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.

Depakote Birth Defect 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 Depakote birth defects side effects, 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.