Can a woman of childbearing age take Depakote (valproate)?

Valproate (Depakote) is Absolutely Contraindicated in Women of Childbearing Potential

Sodium valproate (Depakote) is absolutely contraindicated in women of childbearing potential unless no alternative treatments exist and a strict pregnancy prevention program is implemented. 1

Risks of Valproate in Women of Childbearing Age

Valproate poses significant risks to unborn children when taken during pregnancy:

• Teratogenic effects:

  • Neural tube defects (spina bifida) occur in 1-2 out of every 100 babies born to mothers using valproate during pregnancy 2
  • Other birth defects affecting the heart, head, arms, legs, and urinary tract 2
  • Decreased hearing or hearing loss 2

• Neurodevelopmental effects:

  • Lower IQ in children 2
  • Increased risk of autism or attention deficit/hyperactivity disorder 2
  • Developmental problems with decreased verbal intelligence and communication issues 3

• Pregnancy outcomes:

  • Approximately three-fold increase in major anomalies 3
  • Decreased intrauterine growth 3

Regulatory Position and Guidelines

The evidence is so compelling that regulatory bodies have taken strong positions:

• Valproate is listed as "absolutely contraindicated in women of childbearing potential" in clinical guidelines 1
• The FDA label contains a boxed warning stating "women with menstrual migraine must not take Valproic Acid Oral Solution, USP to prevent migraine headaches" 2
• Women of childbearing potential should be counseled about the risks and alternative treatments before starting valproate 2

Alternative Treatments

For women of childbearing potential requiring treatment for conditions typically managed with valproate:

• For epilepsy: Consider other anticonvulsants such as lamotrigine, levetiracetam, or topiramate (though topiramate is also contraindicated in pregnancy) 1
• For migraine prevention: Beta-blockers (propranolol, metoprolol), topiramate, or amitriptyline 1
• For bipolar disorder: Consider lithium, lamotrigine, or atypical antipsychotics

Special Circumstances

If valproate must be used in a woman of childbearing potential (in extremely rare cases where no alternative is effective):

1. Mandatory pregnancy prevention program must be implemented 4
2. Annual risk acknowledgment form must be completed and signed 4
3. Highly effective contraception must be used 4
4. Regular pregnancy testing should be performed
5. The woman must be fully informed about the risks 4

Conclusion

The evidence is unequivocal - valproate should not be prescribed to women of childbearing potential except in extraordinary circumstances where:

• No alternative treatment options are effective
• The woman cannot become pregnant
• A strict pregnancy prevention program is in place

The risk of serious birth defects and neurodevelopmental disorders far outweighs the benefits in most clinical scenarios, and safer alternatives exist for most indications.