Depakote, Depakote CP and Depakote ER have recently been linked to an increased risk for birth defects in babies born to mothers who take the drug during pregnancy.
If you or somebody you know has taken Depakote while pregnant and given birth to a child with birth defects, you should contact us immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.
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’s the Problem?
Depakote (divalproex sodium and valproic acid) is an anti-seizure medication used to treat a variety of seizure and mood disorders, and to prevent migraines. Unfortunately, Depakote has been linked to a large number of severe, potentially life-threatening birth defects in babies exposed to the drug in the womb, as well as serious side effects in users.
Study Links Depakote to 12X Risk of Spina Bifida
A study published in the New England Journal of Medicine in June 2010 linked Depakote to an increased risk for 16 severe 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,” the researchers concluded.
Depakote Birth Defects
Birth defects linked to the use of Depakote during pregnancy include:
- 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 Low IQ Scores
In May 2013, FDA issued a Drug Safety Communication indicating 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)
The agency found that 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. FDA originally warned about this risk in June 2011.
To learn more about the Depakote birth defects warning, please visit the following page: Valporate Sodium Birth Defects Warning
Depakote and Pregnancy
Do not use Depakote to prevent migraine headaches if you are pregnant. FDA has classified Depakote as a Pregnancy Category X medication, which means that risks to a fetus outweigh any possible benefit for 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 Side Effects
In addition to being linked to birth defects, Depakote may cause the following serious side effects in patients who take the drug:
- Liver Toxicity
- Panic attacks
- And more
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.
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.
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.
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 Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Deapkote lawsuits. We are currently evaluating potential birth defect claims in all 50 states.
Again, if you or somebody you know has taken Depakote during pregnancy and had a child with birth defects, you should contact us immediately. You may be entitled to compensation by filing a lawsuit and we can help.