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FDA announces contraindication of valproate use for migraines during pregnancy!

Earlier this month, the U.S. Food & Drug Administration (FDA) announced that valproate (marketed under the brand name Depakote™) and related products are now contraindicated for migraine treatment during pregnancy. The indication for migraine will be changed from “D” (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to “X” (the risk of use in pregnant women clearly outweighs any possible benefit of the drug). The indications for epilepsy and manic episodes of bipolar disorder resistant to other therapy remain unchanged — pregnancy category “D.”

Valproate is an anti-seizure medication which works by inhibiting sodium-ion channels and also GABA-transaminase, which is an inhibitor of GABA. It is used widely for treatment of epilepsy, anorexia nervosa, panic attacks, generalized anxiety disorder, post-traumatic stress disorder, migraines, bipolar disorder, and mania.[3]

The decision to re-categorize valproate for migraine treatment in pregnancy was based on the results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study which showed that children who were exposed to valproate during pregnancy had decreased IQs compared to children exposed to other anti-epileptic drugs. The data is shown below [1]:

Source: FDA

Valproate is also associated with neural tube defects despite folate supplementation during pregnancy. The development of such defect is multifactorial, however genetic susceptibility increases risk with valproate use.[5]

Treatment for migraines during pregnancy should begin with non-drug therapy such as relaxation, sleep, massage, ice packs, and biofeedback. Drug therapy can include tylenol. Aspirin and NSAIDs should be used with caution as they may have effects on the fetus, especially during the third trimester. Medications such as ‘triptans’ (i.e. sumatripan) and ergot-derivatives should not be used in pregnancy.[4]

Disclaimer:  Please note that the information above has been obtained from multiple sources for the sole purpose of student education and should not be used in the direct care of patients and/or clinical decision making.

References:

1) http://www.fda.gov/Drugs/DrugSafety/ucm350684.htm

2) http://www.acpinternist.org/weekly/archives/2013/5/14/index.html#6

3) http://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0012594/?report=details#how_to_use

4) http://www.ncbi.nlm.nih.gov/pubmed/9825951

5) http://www.ncbi.nlm.nih.gov/pubmed/11422330

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