(July 27, 2011)
On July 1st, the U.S. Food and Drug Administration warned the public about new dangers of the Abbott Laboratories epilepsy drug Depakote. New studies have found that women who take this anti-seizure drug while pregnant increase the risk their babies will end up with some type of cognitive defect.
These findings are backed up by epidemiologic studies that show that children born to mothers who took valproate sodium (the active ingredient in Depakote) scored lower on cognitive tests. Other valproate products include Depacon, Depakene and Stavvzor, and their generics, and are mostly used to treat seizures and symptoms of bipolar disorder, as well as migraine headaches.
The FDA will soon be adding information about the risk of delayed development caused to newborns due to damage caused in utero from mothers’ use of Depakote to the valproate product labels. Long-term effects are still not known in regards to cognitive development.
The agency already warned about the risk of neural tube birth defects from Depakote use during pregnancy back in December of 2009. In fact, when they released that warning, they released an announcement stating that “If the use of valproate is not essential, alternative medications that have a lower risk tot he fetus of birth defects and adverse cognitive effects should be considered in pregnant women and women of childbearing age.”
Depakote already has earned the “Boxed Warning” label by the FDA, which is the highest warning they can require a company to use on it’s drug labeling. This “Boxed Warning” alerts doctors and patients of the serious and life-threatening side effects associated with Depakote use.
If you or a loved one have taken Depakote while pregnant, you may be eligible to file a dangerous drug claim. A dangerous drug attorney from our law firm can help you review your situation, as well as determine if you can file a lawsuit for a dangerous drug injury. call us at 1-800-246-4878.