Depakote and Pregnancy Don’t Mix

Seattle, WAA conscientious doctor might consider asking his or her female patient of child-bearing age if there is even the remotest chance that she could become pregnant before prescribing Depakote. Susan discovered she was pregnant at 10 weeks and is now concerned that her baby could be born with Depakote birth defects.

Susan (not her real name) isn’t alone. Yolanda says she took Depakote back in 2005, but stopped the medication as soon as she realized she was pregnant. But she had taken the drug for the first 12 weeks of her pregnancy and her daughter was born with heart and skeletal defects.

Both Susan and Yolanda were on Depakote as a treatment for epilepsy, but Corina was prescribed Depakote off label for migraines. “I gave birth to my little girl in October of this year and she was born with an extra digit,” she says. “A plastic surgeon removed it and sent it for testing. I can’t stop blaming myself because I was taking Depakote earlier this year and wasn’t aware that I was even pregnant.”

All three women have filed Depakote birth defect claims. Corina’s case is likely more worrisome to Abbot Laboratories, the Depakote manufacturer. Last year Abbot agreed to pay $1.6 billion to settle state and federal claims that it promoted Depakote’s use to treat bi-polar mania and to prevent migraine headaches.

Over the past 10 years, studies published in the New England Journal of Medicine (April 16, 2009 and June 10, 2010) have shown an association with Depakote and birth defects. The researchers associate the medication with such conditions in infants as spina bifida, neural tube defects, cardiac defects, facial clefts, hypospadias, craniosynostosis, limb defects, cleft palate, congenital anomalies and symptoms similar to fetal alcohol syndrome.

The more Corina reads about Depakote side effects, the more worried and angry she becomes. Worried because she doesn’t know if Depakote has done even more damage and angry because her doctor should have warned her. “How could he have not known about the dangers of Depakote?” she asks. “Could he have been so gullible as to believe the Abbot Labs’ sales reps in their quest for putting profit over safety?” I am tempted to file a medical malpractice suit against my doctor for prescribing Depakote off label.”

In August 2013, a federal court complaint was filed accusing Abbott Labs of racketeering in an effort to promote Depakote for unapproved uses (case no. 1:2013cv05865, Illinois Northern District Court), according to Bloomberg.

In April 2013, a number of plaintiffs filed a Depakote lawsuit in Illinois Southern District Court (case no. 3:2013cv00414), claiming they were born with serious birth defects as a result of their mothers’ use of Depkoate during pregnancy. The plaintiffs were born with spina bifida, heart defects and neural tube defects, among other congenital malformations and birth defects.