Depakote, an Abbott Laboratories drug, was approved for use in 1983 by the U.S. Food and Drug Administration. Since that time, it has primarily been used to treat epilepsy and secondarily, depression. Over the years, research has shown the side effects of Depakote to increase the risk of birth defects in infants whose mothers who took the drug even as early as their first trimester. Inadequate warnings by Abbott Laboratories resulted in the use of Depakote by numerous pregnant women throughout the United States, with harmful consequences to their infants.
Please read on to learn more about the Depakote Warning Label Mandate and how to protect your rights:
The Depakote Warning Label Mandate: What is it all about?
In December of 2009, based on data taken from the North American Antiepileptic Drug Pregnancy Registry, the United States Food and Drug Administration issued a mandate for Abbott Laboratories to update the warning label on its drug, Depakote, to make sure that childbearing aged women would be made aware of the risks of major birth defects.
Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects
Information for Healthcare Professionals More...
The Dangers of Depakote:
The New England Journal of Medicine published a study in June of 2010 indicating that women who take Depakote (Valproic Acid) during pregnancy may be 12 times more likely to give birth to infants More...
How We Can Help:
As a qualified products liability law firm, Sullo & Sullo is able to help you in several very important ways: More...