Tuesday, January 12, 2010

Birth Defects Related to Depakote and Similar Drugs

Birth Defects Related to Depakote and Similar Drugs

FDA has notified health care professionals and patients about the increased risk of major birth defects in babies exposed to valproate sodium and related products during pregnancy.

The products are marketed under the following brand names:

  • Depacon (valproate sodium)
  • Depakote, Depakote CP, Depakote ER (dilvalproex sodium)
  • Depakene (valproic acid)
  • Stavzor (valproic acid)

Depending on the products, they may be used to treat epilepsy, bipolar disorder, and migraine headaches.

The risk: There is an increased risk of neural tube defects, such as defects of the brain and spinal cord, and other major birth defects, such as craniofacial defects (abnormally formed face and skull enclosing the brain) and cardiovascular malformations (abnormally formed heart or blood vessels), in babies exposed to valproate sodium and related products during pregnancy.

The medication guide for valproate that is provided with each prescription explains the benefits and risks of valproate and encourages patients to discuss options with their health care professional.


  • Women who are planning a pregnancy or who become pregnant while taking valproate should contact their health care professionals immediately.
  • Valproate should not be stopped without talking to a health care professional, even in pregnant women. Stopping valproate suddenly can cause serious problems.
  • Women who may bear children should only use valproate if it is necessary to manage their medical condition. Talk to your health care professional about the risks and options if you use valproate and you may become pregnant.
  • Women who use valproate and are not planning to get pregnant should use effective birth control.
  • Pregnant women who use valproate or other drugs to treat epilepsy should consider enrolling in the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or visiting www.aedpregnancyregistry.org.

1 comment:

  1. Yes, coordinate with your neurologist, but here is the basic strategy for someone who must stay on Depakote during pregnancy:

    Depakote is a folate antagonist, which does not allow the body to utilize folate. Whether pregnant or not, the patient can counter this by taking up to 10x the recommended folic acid. For pregnancy, you should ramp up the dosage a few months before conception to up to 4000 micrograms, which is 10x the regular 400microgram pill. Take with meals spread throughout the day. Overdose is not harmful, but signs of too much include itchy skin. A person not on depakote may get itchy skin at 1000 micrograms daily, but with Depakote, it may take 5000 micrograms or more.

    The first trimester is the time to take extra folic acid to prevent the neural tube defects. You can decrease slightly in 2nd trimester, but it is good for the mother's health to be on more than the usual amount of folic acid at all times--pregnant or not--maybe 2000 micrograms.

    Other strategies include reducing the dosage of Depakote slightly to assure that the patient is in the lower range of the theraputic dose, but carefully monitoring the blood levels, and usually returning to the usual dosage during the late 2nd trimester when risk of neural tube defects have lessened, but when it is more important for the mother to avoid seizures which would cause more damage to the baby by restricting oxygen.

    Finally, there is a second possible source of sexual organ development birth defects particularly for male babies. Depakote may contain phthalates in its enteric coating, which is an endocrine disruptor. You have to figure out which generic suppliers contain phthalates. We are just starting to investigate this. If anyone has information about phthalates in enteric coatings or in Depakote, please let me know. Thanks.


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