- 1978: The U.S. Food and Drug Administration (FDA) initial approval of Depakene (valproic acid) for the treatment of epilepsy.
- 1983: The U.S. Food and Drug Administration (FDA) approves Depakote® to be marketed in the U.S. for the treatment of epilepsy.
- 1995: Depakote® is approved by the U.S. Food and Drug Administration (FDA) for the treatment of mania associated with bipolar disorder. Lithium was the only FDA-approved drug for mania up until this point.
- 1996: Depakote® is approved by the U.S. Food and Drug Administration (FDA) for migraines.
- 2005: A study reveals an 8.9% rate of developing autism among children exposed to sodium valproate (Depakote) before birth, while the normal rate of incidence for autism in the general population is less than 1%.
- 2008: The first generic version of Depakote® is approved by the FDA.
- 2009: A study found that the 3-year-old child of a pregnant women taking Depakote had an IQ nine points lower than that of a well-matched control group.
- 2009: The U.S. Food and Drug Administration (FDA) asked Abbott Laboratories to add information regarding the North American Antiepileptic Drug (NAAED) Pregnancy Registry to the Depakote® drug label. Depakote® label added a “black box” warning, the most serious type of warning that can be placed on a drug label, regarding hepatotoxicity, fetal risk, and pancreatitis.
We Can Help
If you or a loved one have suffered because of Depakote®, or have been injured, you may be entitled to financial compensation. Recovery may include compensations for your medical bills, pain and suffering, and loss of wages. To find out if you have a claim, please call Avram Blair & Associates, P.C. toll-free at (800) 648-2139 or fill out our online contact form for a free consultation.