New Depakote Birth Defect Warning: Category Change from D to X

This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

The FDA is finally getting around to advising health care professionals and women that the anti-seizure medication Depakote (generics valproate sodium and related products, valproic acid and divalproex sodium) are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. This has been a long time coming.

Although evidence has existed for years of the dangers of taking Depakote during pregnancy, the FDA based the most recent warning on information from a recent study that showed Depakote can cause decreased IQ scores in children whose mothers took them while pregnant. Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from “D” (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to “X” (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).

Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.

A little background on Depakote: Depakote products are approved for the treatment of certain types of epilepsy, the treatment of manic episodes associated with bipolar disorder, and the prevention of migraine headaches. They are also used off-label (for uses not approved by FDA) for other conditions, particularly other psychiatric conditions.

This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showing that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. For additional details, see the Drug Safety Communication Data Summary section.

The FDA recommendation is that Depakote products should not be used in pregnant women for prevention of migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if other treatments have failed to provide adequate symptom control or are otherwise unacceptable.

Women who are pregnant and taking a valproate medication should not stop their medication but should talk to their health care professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby.

The formal FDA recommendation and warning change can be accessed here:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350868.htm?source=govdelivery

If you or a loved one was prescribed Depakote during pregnancy and gave birth to a child with a birth defect or one displaying sign of low IQ, please contact The Michael Brady Lynch Firm for a free, no-obligation, confidential case evaluation.

About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Mirena IUD, Pradaxa internal bleeding, Actos bladder cancer, Fosamax Femur Fractures, and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.

 

 

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