Depakote Pregnancy Side Effects May Be Responsible for Hundreds of Birth Defects in France: Report

France is warning about an alarming number of reports involving birth defects linked to Depakote and other valproate-based drugs, indicating that about 450 babies in that country were born with birth defects after exposure to the epilepsy drug during pregnancy. 

Depakote (valproate) is sold in France under the brand name Depakine by Sanofi, and officials in that country indicate that they will require new warnings on the drug about the pregnancy risks, including congenital birth defects and stillbirths.

The warning will go into effect on March 1, coming after an estimate by the country’s health officials that found hundreds of children may have developed severe malformations or birth defects due to the Depakote pregnancy side effects.

The study focused on births in the Rhone-Alpes region from 2006 to 2014, and then calculated the number of instances for the entire country from those results.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, use of the anti-seizure drug by pregnant women has been linked to a number of potential birth defects from Depakote, 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 defect risk, 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.

In January 2015, the U.K Medicines and Healthcare products Regulatory Agency (MHRA) called 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.

A number of Depakote birth defect lawsuits are being pursued by families throughout the United States, alleging that the drug maker sold Depakote for years without providing adequate warnings for women or the medical community about the potential pregnancy side effects.