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In addition to Depakote / Depakene / Depacon products liability lawsuits against the pharmaceutical company, there may be medical malpractice cases based on the inappropriate prescribing of these drugs and/or the doctor’s failure to adequately warn women of child-bearing years about the increased risk of birth defects even after several revisions to the drug labels about safety were mandated by the FDA.
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Higher Risks Of Neural Tube Defects Like Spina Bifida, Hypospadias, And Other Birth Defects Or Congenital Malformations
Depakote, as well as Depakene and Depacon, are prescription medicines from AbbVie Inc. (formerly Abbott) used:
• to treat manic episodes associated with bipolar disorder
• alone or with other medicines to treat:
• complex partial seizures in adults and children 10 years of age and older
• simple and complex absence seizures, with or without other seizure types
• to prevent migraine headaches
In May 2013 there was a so-called “Black-Box” warning and several other significant label revisions about serious risks for children whose mother used the following anti-seizure medications during pregnancy which were added to the Prescribing Information by FDA and the drug company AbbVie Inc. (formerly Abbott).
What is most remarkable about this May 2013 label revision by AbbVie / Abbott was this new warning: there is a 400% (i.e., four times) increased risk of birth defects, or congenital malformations, associated with the use of Depakote, Depacon, or Depakene during pregnancy.
Stavzor, a lesser known medication from Noven Therapeutics, LLC which was approved by the FDA in 2008 and which had a June 2013 label change similar the the AbbVie / Abbott drugs listed above.
Specifically, these medications have been associated with increased rates of other major congenital malformations, such as craniofacial and cardiovascular defects. For example:
- cleft palate;
- heart defects (such as atrial septal defect);
- polydactyly (multiple fingers or toes);
- craniosynostosis (premature closure of sutures in skull); and,
- hypospadias (abnormal location of urethra in males).
Based on what is known today, here are the two primary take away points:
- Amount of Depacon / Depakene / Depakote / Stavzor taken during the first trimester of pregnancy is a factor; and,
- Use of these medications while pregnant present up to a 400% increased risk of birth defects compared to other anti-seizure medications.
Increased Risk Of Autism Spectrum Disorder (ASD)
In August 2014 the Prescribing Information, or drug labels, for Depakote, Depakote CP, and Depakote ER (divalproex sodium), Depacon (valproate sodium), and Depakene (valproic acid) were updated by the drug company AbbVie Inc. (formerly Abbott) to add a warning about the potential risk for autism spectrum disorders (ASD).
We will continue to monitor these drug safety issues and report new medical findings as well as any further FDA regulatory action concerning Depacon / Depakene / Depakote / Stavzor, valproate medications for seizures, epilepsy, bipolar disorder, and (until recently) migraine headaches.
As regards lawsuits and legal claims, we expect that the Depacon / Depakene / Depakote / Stavzor drug injury litigation which previously was focused on certain types of birth defects or congenital malformations will expand to include cases of autism spectrum disorder (ASD) and autism.
We encourage you to submit a Drug Injury Law Case Review online– it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
Updates Information About Extent Of Serious Developmental Disorders Such As Autism Spectrum Disorders (ASD) As Well As Congenital Malformations And Birth Defects Like Spina Bifida
SUMMARY: On January 22, 2015 the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Drug Safety Alert, “Medicines related to valproate: risk of abnormal pregnancy outcomes”, which has to do with these drugs:
- Depakote, Depakote CP, and Depakote ER (divalproex sodium)
- Depacon (valproate sodium)
- Depakene (valproic acid)
All of these drugs are manufactured and sold by the drug company AbbVie Inc. (formerly Abbott).
The subtitle of this MHRA warning conveys the bottom-line message plain and clear:
Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
We will watch to see if there are any further Depakote / Depacon / Depakene label changes regarding autism and/or birth defects here in the US like those that are forthcoming in the UK, according the January 2015 Drug Safety Update regarding these valproate drugs.
For more about the safety issues concerning these drugs, see our Depakote / Depakene / Depacon drug information page.
Earlier articles by attorney Tom Lamb on the Side Effects Blog:
- European Medicines Agency (EMA) Committee Recommends Further Restrictions On Use Of Depakote / Depakene / Depacon By Women Of Childbearing Age
- Significantly Increased Risk Of Autism Spectrum Disorder (ASD) In Children Whose Mothers Used Depacon / Depakene / Depakote During Their Pregnancy
- Like Depakote, Stavzor Can Cause Liver Failure, Usually During First 6 Months; Children Under Age 2 Are At A Higher Risk, As Are Patients with Mitochondrial Disease
- Higher Risks Of Birth Defects Spina Bifida And Hypospadias Found To Be Dose-Related For Depacon / Depakene / Depakote / Stavzor
- Depacon / Depakene / Depakote: 400% Increased Risk Of Birth Defects Compared To Other Anti-Seizure Medications Used By Mothers With Epilepsy
- Depakote Or Depakene Taken During Pregnancy May Cause Congenital Malformations Or Birth Defects Such As Neural Tube Defects Like Spina Bifida
- Anti-Epileptic Drugs Associated With Birth Defects And Fetal Death