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If you took Depakote while you were pregnant and your baby suffered severe birth defects, our defective drug lawyers may be able to file a Depakote lawsuit to obtain compensation.
Your initial legal consultation with our defective drug attorneys is free and you will not be charged legal fees unless there is a settlement or favorable verdict in your case. We have years of experience fighting for the rights of people injured by dangerous drugs.
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Black Box Warning on Birth Defects
Depakote is an anticonvulsant and mood stabilizer manufactured by Abbot Laboratories that has been prescribed to pregnant women since the 1980s to treat seizure disorders, migraine headaches and bipolar disorder.
However, the U.S. Food and Drug Administration (FDA) did not acknowledge the risk of birth defects until 2006 after the results of a clinical trial were published in Neurology Journal.
Researchers observed 333 pregnant women who were taking one of the following antiepileptic drugs: Depakote, Dilantin, Tegretol or Lamictal.
Approximately 20 percent of women who took Depakote had babies with severe birth defects, the highest rate of birth defects among the four drugs studied. Birth defects from Depakote included:
- Malformed hearts
- Malformed genitals
- Cleft palate
- Artery deformities
- Abnormally developed arms and legs
- Spina bifida
The study led to the FDA adding a black box warning to Depakote packaging advising doctors and consumers of the risk of birth defects when the drug is taken by pregnant women.
The warning also classifies Depakote as a class D drug, because it has been shown to harm fetuses and should be taken during pregnancy only if other medications cannot be used.
If your baby suffered birth defects due to Depakote, our defective drug lawyers may be able to file a Depakote lawsuit to recover compensation.
Other Black Box Warnings About Depakote
In addition to birth defects, Depakote’s black box warning says there have been cases of life-threatening pancreatitis in children and adults who took this medication. In some cases, there was a rapid progression from displaying symptoms to death.
The warning advises Depakote users to seek medical treatment immediately if they experience any symptoms of liver damage or pancreatitis, including:
- Upper stomach pain
- Clay-colored stool
- Bloody urine
- Fever, chills or swollen glands
The black box warning also says that Depakote has caused fatal liver failure in some patients. Children under two years of age are at increased risk, particularly if they are taking multiple anticonvulsant medications or if they have congenital metabolic disorders, severe seizure disorders or organic brain disease.
Most incidents of fatal liver failure occurred during the first six months patients took Depakote. Life-threatening or fatal liver failure is often preceded by the following symptoms:
- Edema in the face
- Loss of seizure control in epileptic patients
The FDA warning advises doctors to monitor patients closely for any signs of liver failure and to perform liver function tests regularly, particularly during the first six months of treatment.
More Warnings About Depakote
Since issuing the black box warning in 2006, the FDA has issued multiple alerts about severe side effects from Depakote.
A 2009 drug alert said Depakote, when taken during pregnancy, increased the risk of neural tube defects in newborns.
A 2011 warning said studies showed mothers who took Depakote while pregnant had children who scored lower on IQ tests and cognitive tests than other children.
In 2013, the FDA released an advisory to medical professionals stating that they should not prescribe Depakote for the treatment of migraine headaches in pregnant women.
The advisory also said patients with epilepsy or bipolar disorder should not take Depakote unless there was a reason they could not take other drugs.
If Depakote caused you to suffer severe side effects, our defective drug attorneys may be able to file a Depakote lawsuit to obtain fair compensation.
Find Out About Filing a Depakote Lawsuit
Unfortunately, FDA warnings about Depakote side effects did not come soon enough for pregnant women whose children must live the rest of their lives with severe birth defects.
Warnings also came too late for patients who experienced severe damage to their liver or pancreas.
Victims of Depakote side effects have legal options, which may include filing a Depakote lawsuit against the manufacturer for failing to adequately warn consumers and doctors about the severe risks of this medication.
Our attorneys will work tirelessly to obtain all of the evidence we need to build a strong case that has a great opportunity to have a favorable outcome.