Food and Drug Administration FDA approved Depakote in for epilepsy treatment, in for bipolar disorder and in for the prevention of migraine headaches. A study published in the New England Journal of Medicine indicated that children whose mothers took Depakote during the first trimester of pregnancy are more than 12 times more likely to be born with spina bifida, a neural tube defect that results from the spinal column not completely closing during fetal development, leaving the spinal cord exposed.
We are handling individual litigation nationwide and currently accepting new cases in all 50 states. According to the New England Journal of Medicine June 10,children born to women who took valproic acid Depakote or Depakene during the first trimester of pregnancy are much more likely to have serious births defects affecting the brain, heart and limbs, and: In addition, valproate can cause decreased IQ scores following in utero exposure For seizures, the recommended initial dose depends on the weight of the patient.
Published epidemiological studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed in utero to either another antiepileptic drug or to no antiepileptic drugs Collectively, these drugs are known as valproate products. It was first approved by the U.
The results of the NEAD study led to a Black Box warning from the FDA in Octoberincluding hepatoxicity chemical driven liver damageteratogenicity the capability of producing fetal malformation and pancreatitis the inflammation or infection of the pancreas. Depakote is approved by the FDA to treat epilepsy, bipolar disorder and migraine headaches. Depakote has been approved for use in adults and children 10 and older for seizure treatment and age 16 and older for migraine prevention.
What is the risk of having a baby born with Depakote birth defects?
Thoughts about suicide or dying Attempts to commit suicide New or worsening depression New or worsening anxiety Feeling agitated or restless Panic attacks Trouble sleeping insomnia. Depakote has been approved for use in adults and children 10 and older for seizure treatment and age 16 and older for migraine prevention.
Safety recommendations do not exist for the use of valproate in the treatment of seizures at doses above 60 mg a day. Depakote has also been linked to birth defects and liver failure.
Abbott, Abbvie, bipolar disorder, birth defects, black-box-warnings, Depacon, Depakene, Depakote, drug injury, drug safety alert, epilepsy, FDA, fetal risks, migraine headaches, seizures, spina bifida Reblog 0. Current Drug Injury Cases See an up-to-date list of unsafe drugs for which lawsuits are being filed.
We'll take it from here. In cases of Depakote overdose, hemodialysis a process of purifying the blood or hemodialysis used along with hemoperfusion a technique for removing poisons from the blood can result in significant drug removal since the amount of drug that does not bind to protein in the body is high. Women who took Depakote have a four-time greater risk of having a baby with birth defects than those who did not.
Terry received his B. Depakote should be used as an alternative for patients requiring smaller doses than that available with Depakote ER. Drug Safety Developments On our Drug Safety Developments blog there are posts about regulatory actions, medical studies, and journal articles.