Update: Risks of Depakote During Pregnancy Still Unknown to Many, EMA Declares
September 27, 2017 – More than 3 decades after concerns were first raised about the risk of birth defects in children born to women who take Depakote during pregnancy, many expecting mothers are still unaware of the startling correlation, according to the European Medicines Agency (EMA). The agency on Tuesday convened a hearing in London in which it invited citizens of the EU to share their experiences with Depakote.
What is Depakote?
Depakote (valproic acid), manufactured by Abbott Laboratories, has been on the market since 1993. It is used to treat seizures associated with epilepsy, bipolar disorder, depression, and migraine headaches. It is also used “off-label” to treat a variety of psychiatric disorders and other medical conditions.
Depakote and Pregnancy
Do not use Depakote to prevent migraine headaches if you are pregnant. Depakote is “Pregnancy Category X,” which means that the FDA has determined that the risks to a fetus outweigh any possible benefit of preventing headaches. For pregnant women with epilepsy or bipolar disorder, Depakote is “Pregnancy Category D.” Women of childbearing age should not take Depakote unless it is absolutely essential to the management of a serious medical condition.
Depakote Birth Defects
When taken during pregnancy, Depakote may increase the risk that exposed fetuses will be born with one or more of the following congenital abnormalities:
- Spina Bifida
- Atrial Septal Defects (ASD)
- Ventricular Septal Defects (VSD)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Respiratory Distress Syndrome (RSD)
- Tricuspid Valve (Ebstein’s Anomaly)
- Mitral Valve Prolapse
- Transposition of the Great Arteries (TGA)
- Transposition of the Great Vessels (TGV)
- Tetralogy of Fallot (TOF)
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Atresia
- Aortic Stenosis
- Pulmonary Atresia (PA)
- Patent Forman Ovale (PFO)
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Tricuspid Valve Stenosis
- Vascular Ring
- Heart Murmur
- Enlarged Heart
- Pulmonary Stenosis
- Gastroschisis – abdominal wall defect
- Diaphragmatic Hernia
- Craniosynostosis (aka Clover Leaf Skull)
- Chiari Malformation
- Esophageal Stenosis
- Anal Atresia
- Imperforate Anus
- Cleft Palate
- Missing Limbs
- Cerebral Palsy
- Tethered Spinal Cord
- Cryptorchidism (undescended testicles)
- Vesicoureteral Reflux (VUR)
- Renal Agenesis
- Renal Dysplasia
- Renal Hypodyspasia
- Renal Hypoplasia
- Ectopic Kidney
Anti-Seizure Medications Linked to Lower IQ Scores
In May 2013, the U.S. Food and Drug Administration (FDA) warned that pregnant women who take valproate medications during pregnancy could have a baby with birth defects and lower IQ. Drugs in the valproate class include:
- Depacon (valproate sodium)
- Depakote, Depakote CP, Depakote ER (dilvalproex sodium)
- Depakene (valproic acid)
- Stavzor (valproic acid)
Exposure to Depakote or other valproate drugs during fetal development decreases a child’s IQ at age six by 8-12 points compared to children exposed to other anti-epileptic drugs. The FDA originally warned about this risk in a Safety Communication published in June 2011.
According to the FDA:
“Taking valproate during pregnancy can decrease your child’s IQ. There is also a higher risk of birth defects if you take valproate during pregnancy.”
The FDA previously warned about the link between Depakote and birth defects in 2009. Studies showed that the risk of birth defects was almost 4-times higher for babies exposed to valproate drugs than babies exposed to other anti-epileptic drugs.
In real numbers, approximately 10-20% of babies exposed to Depakote will have a birth defect, and 1 out of 20 exposed in the first trimester will have a neural tube defect like spina bifida. For non-exposed babies, just one in 1500 develops spina bifida, and 2-4% have a birth defect.
Study Links Depakote to 12X Risk of Spina Bifida
In June 2010, a study published in the New England Journal of Medicine linked Depakote to a significantly increased risks of 16 birth defects, including:
- Spina bifida — 12.7-fold increased risk
- Craniosynostosis — 6.8-fold increased risk
- Cleft palate — 5.2-fold increased risk
- Atrial septal defect — 2.5-fold increased risk
- Hypospadia — 4.8-fold increased risk
- Polydactyly — 2.2-fold increased risk
“The use of valproic acid monotherapy in the first trimester was associated with significantly increased risks of several congenital malformations, as compared with no use of antiepileptic drugs or with use of other antiepileptic drugs.”
Abbott Must Pay $38 Million in Depakote Spina Bifida Lawsuit
September 14, 2017 – The Supreme Court of Missouri has sustained a jury’s award of $38 million to a girl born with spina bifida after her mother took Depakote during pregnancy, ruling there was evidence that Abbott knew the birth defect risk printed on the drug was more severe than the verbiage suggested.
Illinois Jury Awards $15 Million in Depakote Spina Bifida Lawsuit
July 15, 2017 – An Illinois jury has awarded $15 million to a woman who claimed that her son was born with spina bifida as a result of her use of Depakote while pregnant. According to the lawsuit, AbbVie failed to adequately warn of the severe side effects of Depakote, and as a result she was unknowingly prescribed a drug during pregnancy which would result in life-threatening birth defects.
Special Master Appointed in Depakote Birth Defects Trial
April 11, 2017 – U.S. District Judge Nancy J. Rosenstengel has tapped retired state judge Daniel J. Stack as special master in an upcoming trial alleging spina bifida from Depakote. Stack’s initial role will be to organize the parties’ objections to deposition designations and then make recommendations on those issues, but these duties may be expanded before the trial begins next month.
Depakote Linked to 4,000+ Birth Defects in France
April 20, 2017 – Up to 4,100 children in France were born with major congenital malformations between 1967 and 2016 after their mothers used Depakote during pregnancy, according to a study by the French National Agency for the Safety of Medicines (ANSM). Birth defects linked to Depakote included spina bifida, heart malformations and genital defects.
Judge Upholds $38 Million Depakote Settlement
February 6, 2017 – A St. Louis judge has affirmed a $38 million payout to a girl who was born with spina bifida and other severe birth defects after her mother took Depakote during pregnancy. In May 2015, a St. Louis jury awarded $15 million in compensatory damages and $23 million in punitive damages to Maddison Schmidt after finding that Abbott had failed to warn her mother about the risk of birth defects with Depakote. Abbott appealed the verdict and requested a new trial; however, in November 2016, the Missouri Court of Appeals upheld the award.
Do I have a Depakote Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Depakote lawsuits. We are handling individual litigation nationwide and currently accepting new birth defect cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one took Depakote during pregnancy and had a baby with a birth defect, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.