Baron & Budd is currently investigating possible lawsuits regarding the use of the drug Depakote and birth defects. Sadly, a possible connection has been found between Depakote and numerous physical birth defects, such as Fetal Valproate Syndrome and others. Our Depakote lawyers are on it, working to hold the drug’s manufacturer accountable for negligence. To see if you qualify for a Depakote lawsuit, contact us at 866-520-2755 or email us here.
How To Take Part In A Depakote Lawsuit
- Fetal Valproate Syndrome
- Abnormal Digits
- Aortic Stenosis
- Club Foot
- Club Hands/Fingers
- Spina Bifida
- Tetralogy of Fallot
- Ventricular Septal Defects
- Other cardiac or neural tube defects
What Is Depakote?
Depakote is an anti-seizure medication. Depakote is often called:
- Valproic acid or valproate
- Depakene — a brand name of Depakote
- Depakote ER —the extended release version of Depakote
- Divalproex Sodium
- Valproate sodium or Depacon
Whatever the name, Depakote works by helping to balance neurotransmitters in the brain. Depakote is used to treat epilepsy, several types of seizures, as well as the acute manic phase of bipolar disorder. Depakote may also be prescribed to prevent migraine headaches. Depakote is also prescribed for off-label, or unapproved, uses for other psychiatric conditions including attention deficit disorder (ADHD) or choreo (hyperactive movement disorder).
A variety of patients may be prescribed Depakote to treat their symptoms. (Remember the different names of Depakote we mentioned above? That is because different names are used to treat different ailments.) However, the two most common patients who are prescribed Depakote are those who are suffering from forms of epilepsy or from the manic phase of bipolar disorder.
For Epilepsy: Depakote has been used to treat epilepsy for decades. According to the Depakote website itself, epilepsy is the third most common neurological disorder in the United States, after Alzheimer’s and stroke.
For Bipolar Mania: Depakote is a very popular drug used to treat the acute manic phase of bipolar disorder. Depakote is also prescribed to treat mixed episodes associated with bipolar disorder and RC (rapid cycling bipolar disorder). While Depakote may be prescribed along with other prescriptions in order to treat forms of bipolar, Depakote is typically the “main” drug depended on for treatment.
And that brings us to the problem, for both epileptic and bipolar patients alike: the dangerous side effects that may come with taking Depakote while pregnant.
The FDA notified patients and healthcare professionals about an increased risk of serious birth defects in babies that were expose to Depakote in the womb.
Yet, while the notice was necessary, it was also all too late. By the time the first notice was made public, Depakote had been on the market for decades — and during that time, patients and healthcare professionals were not properly warned of the risks.
The birth defect risks associated with Depakote can be devastating. It has been shown that women who took Depakote during the first trimester of pregnancy were much more likely to give birth to children with serious birth defects. Many of the women who were prescribed Depakote did not know that they were pregnant until they were well into their first trimester or already in their second trimester; meaning their babies were already exposed to the harmful effects of the drug. That is why it is so critical that patients and healthcare professionals should have been told sooner.
In a study published in the New England Journal of Medicine in 2010, European researchers noted an increased risk of six different types of birth defects when Depakote was taken just in the first trimester. The risk for spina bifida (a defect of the spine and spinal cord) was especially high. Mothers who took Depakote during the first trimester were 12.7 times more likely to give birth to a baby with spina bifida.
Another figure to be aware of is 20 percent. As in: 20.6 percent of infants whose mothers had taken an anti-seizure medication like Depakote during their pregnancy had serious birth defects. This study was performed over a seven-year period and involved more than 1,000 births at five hospitals in the Boston area. (See Lewis B. Holmes, M.D., Elizabeth A. Harvey, Ph.D., M.P.H., Brent A. Coull, Ph.D., Kelly B. Huntington, B.A., Shahram Khoshbin, M.D., Ailish M. Hayes, M.D., and Louise M. Ryan, Ph.D., The Teratogenicity of Anticonvulsant Drugs. N Engl J Med, April 12, 2001; 344:1132-1138.)
Three major warnings:
2006: The FDA added a black-box (i.e., the most serious) warning about possible birth defects.
2009: The FDA warned about neural tube, craniofacial and heart birth defects — all birth defects linked to taking Depakote while pregnant.
2011: The FDA warned patients and healthcare professionals that taking Depakote while pregnant may result in having babies with a decreased cognitive function (as in a lower IQ). This warning came after studies showing that children born to mothers who took Depakote during their pregnancy often had lower I.Q. scores compared to children born to mothers who did not take Depakote.
The FDA has also stated that: “Women who may bear children should only use valproate if it is necessary to manage their medical condition.” That means: Depakote is a drug with serious risks.
It is the fault of the drug maker, Abbott Laboratories (and now Abbott’s subsidiary AbbVie) a Big Pharma company that manufacturers and markets pharmaceutical drugs for patients around the world.
Why is it their fault? Because the pharmaceutical company failed to protect you and your loved ones. Abbott should have placed warnings and cautioned doctors and the women the doctors were treating about the risks of harmful birth defects. Instead of behaving like a responsible corporation and coming forward when the studies showing the devastating birth defects that were being published like a responsible corporation, it took the FDA to step in and make Abbott place a black-box warning on Depakote to help warn patients of the risks of taking Depakote while pregnant.
Had women of childbearing years known of the risks before taking Depakote, then they could have worked with their doctors to find a safer alternative treatment. A drug that has associated risks within the first trimester of pregnancy is a serious thing — one that all women taking the drug should have known about, whether they were pregnant at the time or not.
Believe it or not, this is not the drug makers’ first time in the limelight. In fact, Abbott marketed Depakote for the unapproved treatment of schizophrenia even though there was little evidence that Depakote helped patients with schizophrenia. Likewise, Abbott heavily marketed Depakote to the caretakers of elderly patients to treat their patients’ dementia.