Epilepsy Drug Pregnancy Risks Linked to Major Birth Defects and Congenital Malformations: Study

Side effects of the epilepsy drugs Depakote and Topamax have been linked to a number of different forms of birth defects and congenital malformations when taken during pregnancy, according to the findings of new research.

In a study published last week in the medical journal Neurology, French researchers looked at multiple types of epilepsy drugs to evaluate the pregnancy risks. However, out of 10 different drugs tested, they only found major problems linked to the use of valproic acid, sold under the brand name Depakote, and topiramate, sold under the brand name Topamax.

The nationwide cohort study looked at data from French health care databases, which included all pregnancies lasting 20 weeks or more between January 2011 and March 2015. They looked at 10 different antiepileptic drugs (AEDs) and 23 different major congenital malformations which occurred up to 12 months after birth, or 24 months for certain deformities such as microencephaly, hypospadias and epispadias.

According to the findings, only Depakote and Topamax were associated with malformations. Topamax was linked to eight different types of major malformations, as well as an increased risk of cleft lip. They also noted there were three other possible signals for malformations.

“These results confirm the teratogenicity of valproic acid and topiramate,” the researchers concluded. “Because of the small numbers of cases and possible confounding, the other 3 signals should be interpreted with appropriate caution.”

Depakote Birth Defects

Depakote (valproate) is prescribed for treatment of seizures and bipolar disorder, as well as migraine headaches, but has been linked to a number of serious health concerns for unborn children when used by pregnant women.

In 2006, the FDA added a “black box” warning about the potential Depakote pregnancy 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 and AbbVie, a subsidiary it spun off, have faced hundreds of Depakote lawsuits in state and federal courts nationwide. Plaintiffs say the company should be held liable for failing to warn women and the medical community about the risks associated with using the medication during pregnancy.

Topamax Birth Defects

Topamax (generic topiramate) was approved by the FDA in 1997, and it has been available as a generic since 2006. It is approved for the treatment of epilepsy, migraines and to promote weight loss and has also been linked to birth defects in the past.

Johnson & Johnson has maintained that adequate Topamax warnings were provided. However, in March 2011, the FDA issued a warning about the Topamax oral cleft birth defect risk among babies born to mothers who took the drug during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.

Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.