Drugs
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Valproate Information
Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.
Valproate products include: valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
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Related Information
FDA Drug Safety Podcast for Healthcare Professionals: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
7/1/2011FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
6/30/2011Questions and Answers: Children born to mothers who took the anti-seizure medication Valproate while pregnant may have impaired cognitive development
6/30/2011Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate
12/3/2009Suicidal Behavior and Ideation and Antiepileptic Drugs FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
12/16/2008Information for Healthcare Professionals: Suicidal Behavior and Ideation and Antiepileptic Drugs
12/16/2008FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications
1/31/2008
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Labeling and Regulatory History from Drugs@FDA
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