The anticonvulsant drug Depakote (valproic acid) has been linked to a number of serious birth defects, including spina bifida, fetal trauma, fetal death, and malformations of the mouth, heart, hand, ribs and urethra. The United States Department of Justice is currently investigating the maker of Depakote, Abbott Pharmaceuticals, for illegally marketing Depakote for unapproved purposes. Many parents of children injured by the mother’s use of Depakote while pregnant have filed lawsuits alleging Abbott Pharmaceutical did not properly test the drug and failed to warn doctors and patients of the true dangers of taking the medication, particularly when they could become pregnant.
Depakote, usually made as valproate semisodium or divalproex sodium, was initially approved by the Food and Drug Administration in the 1980s as a treatment for epilepsy. For more than 20 years, Abbott Pharmaceuticals lobbied the FDA to approve Depakote for other purposes. In 1995, the FDA approved marketing of Depakote to treat mania arising from bipolar disorder, and in 1996 the FDA approved marketing of the drug for the prevention of migraine headaches. Abbott Pharmaceuticals, however, allegedly went far beyond that approved marketing and illegally lobbied doctors to start prescribing Depakote for much more common — and thus much more profitable — uses such as a mood stabilizer and a treatment for depression and aggression. In October 2011, it was reported that effort pharmaceuticals has set aside more than $1.5 billion to settle government charges related to its illegal marketing of “off label” uses.
“Off label” use, in which physicians prescribed Depakote for purposes not approved by the FDA, has inflicted tremendous damage on women who took Depakote before becoming pregnant or while pregnant. As many studies, such as a review in the November 2009 edition of Neurological Clinics, have concluded that even in patients with severe epilepsy, “valproate should not be a first-line [antiepilectic] for women who are considering pregnancy.” Depakote is known to cause birth defects like spina bifida and a cleft palate; as the Pharmacopoeia of Prophylactic Antiepileptic Drugs concludes, “an estimated 1–2% risk of neural tube defects, predominantly spina bifida aperta, in babies of women on valproate is well established.” Many physicians prescribing Depakote, however, were unaware of that risk, and the warning label itself on the medication made no mention of this risk until 2007.
If your child was born with spina bifida or another birth defect after you took Depakote, contact our attorneys for a free, confidential consultation by using the form on the right or by calling my office at (215) 931-2634. You can also read more about our dangerous drug lawyers.