FDA Reclassifies Depakote For Migraine Prevention, Due To A Link To Lower IQ Scores

June 4, 2013 | By O'Connor Acciani & Levy
FDA Reclassifies Depakote For Migraine Prevention, Due To A Link To Lower IQ Scores

More information has surfaced about the potential risks of using Depakote during pregnancy.  A Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study released the final results of an examination of the effect of anti-epileptics, such as Depakote, on a child's IQ score. The NEAD study indicated that children whose mothers were exposed to Depakote during pregnancy tended to have an IQ score 8 to 10 points lower than children whose mothers used other anti-epileptics.  In response to this finding, On May 5, the U.S. Food and Drug Administration (FDA) released a safety announcement advising patients about the dangers related to taking Depakote to treat migraines during pregnancy. If you took Depakote while you were pregnant and your child was born with birth defects contact one of our trusted personal injury attorneys in Cincinnati today for a free legal consultation. Depakote is commonly used to treat epilepsy and bipolar disorder.  However, it is also sometimes prescribed as a treatment for depression, neuropathy and migraines. The safety announcement stated the FDA's intention to add stronger warnings about the use of Depakote during pregnancy to the drugs label.  The FDA also expressed their intention to change Depakotes pregnancy category for treating migraines from category D (meaning that the potential benefit of using the drug during pregnancy may be acceptable, despite the risks) to category X (that the risk of using Depakote during pregnancy clearly outweighs the benefits). The FDA stressed that Depakote will still remain a pregnancy category D drug for treating epilepsy and bipolar disorder, because the benefits of controlling the mothers seizures may outweigh the potential risks to the fetus.  The announcement urged that pregnant women with epilepsy or bipolar disorder should only take Depakote if other medications are not effective at controlling their disorder. It has been known for some time that Depakote and the other valproate products, when taken during pregnancy, have been linked to severe birth defects and cognitive deficits in the child.  According to the drugs label, the risk of birth defects from Depakote use during pregnancy is up to 4 times higher than other anti-epileptic medication. If you believe that your child has been the victim of birth defects such as spina bifida, cleft palate, heart defects, limb defects or cognitive deficits, then call our office for a free consultation.  Our firm is currently involved in Depakote litigation to seek compensation for clients who have suffered from birth defects linked to Depakote use.  Call our office today at (877) 288-3241 Additional note: The FDA strongly recommends that women who are pregnant and are currently taking Depakote should not stop taking the drug immediately, because of the potential for life-threatening medical problems associated with suddenly stopping treatment.  If you are pregnant, and currently take Depakote or another valproate product, then you should talk to your doctor about the risks and benefits of using Depakote during pregnancy.