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Valproate and Pregnancy

The Food and Drug Administration (FDA) has issued a reminder that valproate and pregnancy don't mix. Indeed, say officials, the risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, may be 30 to 80 times higher in fetuses exposed to valproate sodium (Depacon), valproic acid (Depakene, Stavzor), or divalproex sodium (Depakote). These drugs may be used to treat epilepsy, bipolar disorder, and migraine headaches.
   The FDA is working with drug makers to devise appropriate label changes for these drugs. Meanwhile, officials urge health care professionals to communicate carefully about the risks of taking valproate during pregnancy.

  • Explain the risks of the patient's medical condition and the use of valproate.
  • Explain that taking valproate may greatly increase the risk of neural tube defects (to 1 in 20 babies), especially when taken early in pregnancy.
  • Stress that women of childbearing potential who take valproate must use effective contraception.
  • Explain that women of childbearing potential should take these drugs only if their medical condition can't be managed without them.
  • Suggest that women of childbearing potential explore other treatments if their medical condition isn't life-threatening.










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