The Chicago Tribune recently reported that Abbott Laboratories is under investigation for their sale and marketing practices of Depakote. Depakote is prescribed primarily to treat bipolar disorder. In certain cases, it is also used to treat major depressive disorder, epilepsy, chronic pain associated with neuropathy, and migraine headaches. The federal probe was initiated to find out if Abbott violated civil or criminal laws in marketing Depakote. Among the laws the federal government is investigating is a violation of the Federal Food, Drug, and Cosmetic Act, a set of laws passed to allow the FDA to oversee the safety of food, drugs, and cosmetics.
DEPAKOTE AND FDA WARNINGS
Depakote has a history of being a problematic drug, and the FDA has issued numerous safety alerts modifying its warning label. In September 2000, the FDA required Depakoteâ€™s first black-box warning due to reports of life-threatening pancreatitis from users of the drug. In January 2007, the FDA issued another warning revising Depakoteâ€™s label due to its risk of causing severe birth defects in pregnant women. This warning came on the heels of a studyreleased in August 2006 asserting that birth defects and fetal death were more common in women who took Depakote while pregnant than women on other epileptic drugs.
Birth defects that may result from Depakote use include:
- Spina Bifida: A birth defect in which some verterbrae of an infant’s spine do not completely fuse and the spinal column fails to completely develop. This condition commonly leads to disability.
- Cleft Palate: This defect occurs when the two plates of the skull that form the roof of the mouth are not completely joined.
In May 2009, the FDA issued another safety alert due to the use of Depakote being potentially associated with an increase in suicidal behavior or thoughts about suicide. Depakote’s label was again changed to accommodate this new risk.
INJURED? PINTAS & MULLINS LAW FIRM IS HERE TO HELP.
If you or a loved one has had a baby with birth defects, and you suspect Depakote may have been the cause, contact an experienced Chicago personal injury attorney at Pintas & Mullins Law Firm. Our attorneys have over twenty years of experience in drug litigation. Call for a free, no-obligation consultation to learn about your legal rights today.