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FDA Drug Safety Communication:
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Valproate Sodium and related products (valproic acid and divalproex sodium): Risk
of Birth Defects
Audience: Neuropsychiatric and Obstetrical healthcare professionals
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The Depakote Warning Label Mandate:What is it all about?
[Posted 12/03/2009] The FDA notified health care professionals and patients about the increased
risk of neural tube defects and other major birth defects, such as craniofacial defects and
cardiovascular malformations, in babies exposed to valproate sodium
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and related products (valproic acid and divalproex sodium) during pregnancy.
Healthcare practitioners should inform women of childbearing potential about these risks,
and consider alternative therapies, especially if using valproate to treat migraines or
other conditions not usually considered life-threatening.
Women of childbearing potential should only use valproate if it is essential to manage
their medical condition. Those who are not actively planning a pregnancy should use
effective contraception, as birth defect risks are particularly high during the first
trimester, before many women know they are pregnant. A valproate Medication Guide,
provided with each outpatient prescription, will explain the benefits and risks of
valproate and encourage patients to discuss options with their healthcare professional.
Pregnant women using valproate or other AEDs should be encouraged to enroll in the North
American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334; www.aedpregnancyregistry.org).
[12/03/2009 - Information for Healthcare Professionals - FDA]
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While Sullo & Sullo, LLP has posted the aforementioned material from the United States
Food & Drug Administration for you to view, this information is NOT constantly updated,
and could be out of date. For the latest updates and information on this particular topic,
you are strongly urged to visit the link posted below:
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman MedicalProducts/ucm192788.htm
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Recent Articles and Publications
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September 05, 2011
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Depakote Birth Defects: Real Risks
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Depakote is a prescription drug used to treat epileptic seizures, psychological disorders such as bipolar disorder, and migraine headaches. Depakote is marketed under several brand names and generic versions of the drug, including Depakote ER, Depakote Sprinkles, Depakene, and Valproate.
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