New FDA Guidelines for Valproate Use in Pregnancy

The FDA (U.S. Food and Drug Administration) recently announced changes in the Pregnancy category for valproate. Valproate products include valproate sodium (Depacon), valproic acid (Depakene and Stavzor), and divalproex sodium (Depakote). The valproates are categorized as anticonvulsants and mood stabilizers. The valproates are used in the treatment of seizure disorders, migraine headaches, bipolar disorder, and more recently, neuropathic (nerve) pain. Valproate has now been placed in the X pregnancy category by the FDA indicating that the medication is contraindicated for use during pregnancy for the treatment of migraine headaches. Valproate will remain in the D pregnancy category for treatment of seizures and bipolar disorder. Pregnancy category D indicates that there is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). [1]


The change in the pregnancy category comes after data from the NEAD study indicated children who were exposed to valproate during pregnancy had lower IQ scores at both 3 years and 6 years of age. [2] [3] The FDA had previously rated the valproates as class D during pregnancy, because there is an increased risk of neural tube defects (spina bifida), cardiac defects, and other minor birth defects with use of these medications.


Preconception counseling by a qualified medical care provider is advised for women with chronic medical conditions to allow for review of current medications and a discussion about the potential risks/benefits of each medication before pregnancy occurs to prevent untoward effects on the fetus. There are several medications for the treatment of seizures and mood disorders on the market that are lower in risk and should be considered for women of childbearing potential.


Mothers who are currently pregnant and taking valproate should not discontinue their medication suddenly but should consult their physician as soon as possible to discuss treatment options. Sudden discontinuation of valproate could result in significant adverse effects on both the mother and her fetus. [1]


References

  1. U.S. Food and Drug Administration. (2013, May 5). FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children. Retrieved from www.fda.gov/Drugs/DrugSafety/ucm350684.htm on 5/13/2013.
  2. Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurology 2013; 12 (3): 244-52.
  3. Meador KJ, Baker GA, Browning N, et al. Cognitive function at 3 years of age after fetal exposure to antiepileptic drugs. N Engl J Med 2009 Apr 16; 360 (16):1597-605.
  4. Cynthia Pride, MSN, CPNP
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