May 7, 2013 – Expecting mothers should avoid using valproate sodium and related drugs to prevent migraine headaches during pregnancy, according to a warning issued this week by the U.S. Food & Drug Administration (FDA). These medications, which include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and all generic equivalents, have recently been linked to lower IQ scores in children exposed in the womb. The new warning comes on the heels of the results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study, which determined that children whose mothers took valproate and related drugs during pregnancy had IQ scores that were 8 to 11 points lower at age 6, compared with children who were exposed to other types of anti-epileptic drugs in the womb.
Free Valproate Lawsuit Evaluation: If you or a loved one has a child who was born with a birth defect after the mother took valproate or other related during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Depakote and we can help.
What’s the Problem?
According to the FDA press release, each of the above-listed medication’s pregnancy category will be changed for migraine use from D (the possible benefits might outweigh the potential risks) to X (the risks clearly outweigh any potential benefits).
“Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their healthcare professional immediately,” according to the FDA. “Women should not stop taking their medication without talking to their healthcare professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus.”
These drugs previously came with boxed warnings regarding use by women of childbearing potential, citing the potential risks of neural tube defects and other major congenital problems in babies exposed to the medications in utero. The labels stated that these drugs should be avoided in women of childbearing potential “unless the drug is essential to the management of her medical condition.”
The pregnancy category remains D when the drugs are used to treat manic episodes associated with bipolar disorder and epilepsy.
“With regard to valproate use in pregnant women with epilepsy or bipolar disorder, valproate products should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable,” the FDA stated.
Do I Have a Valproate Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Valproate lawsuits. We are handling individual litigation nationwide and currently accepting new Valproate birth defect cases in all 50 states.
Free Valproate Lawsuit Evaluation: If you or a loved one has a child who was born with a birth defect after the mother took Valproate or any other related drug listed in this article during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a Depakote birth defects suit and we can help.