Is Vistaril (hydroxyzine) safe to use during pregnancy?

Hydroxyzine (Vistaril) in Pregnancy

Hydroxyzine is contraindicated during pregnancy, especially in early pregnancy, due to inadequate safety data and potential fetal risks. 1

Safety Classification and Risks

• Hydroxyzine is specifically contraindicated during the early stages of pregnancy according to its FDA drug label and manufacturer's Summary of Product Characteristics 1, 2
• Clinical data in humans are inadequate to establish safety in early pregnancy 1
• When administered to pregnant mice, rats, and rabbits, hydroxyzine induced fetal abnormalities at doses substantially above the human therapeutic range 1
• Hydroxyzine falls under the former FDA pregnancy category C, indicating that animal studies have shown adverse effects on the fetus, but adequate studies in pregnant women are lacking 2

Recommendations for Management

• Avoid all antihistamines in pregnancy when possible, especially during the first trimester 2
• If antihistamine therapy is necessary during pregnancy:
  • Consider chlorphenamine (chlorpheniramine) as an alternative, which is often chosen by clinicians due to its long safety record 2
  • Loratadine and cetirizine (which is actually a metabolite of hydroxyzine) are classified as former FDA Pregnancy Category B drugs, suggesting no evidence of harm to the fetus, though well-controlled human studies are limited 2

Clinical Considerations

• For patients who were exposed to hydroxyzine before pregnancy was known:

  • Individual risk assessment is necessary 3
  • A risk management strategy should be determined 3
  • Consultation with a specialist in maternal-fetal medicine may be warranted

• For patients requiring treatment for anxiety or allergic conditions during pregnancy:

  • Select medications with better established safety profiles 2
  • Consider non-pharmacological approaches when appropriate
  • If medication is necessary, choose alternatives with more favorable pregnancy safety data 2

Common Pitfalls and Caveats

• Many medications lack adequate safety data in pregnancy, with approximately one-quarter having insufficient evidence to characterize their safety profile 4
• Unplanned exposure to medications early in pregnancy often causes excessive maternal and physician anxiety 5
• The contraindication for hydroxyzine in pregnancy is explicit in the FDA labeling, making it a clear medication to avoid 1
• When evaluating medication safety in pregnancy, it's important to weigh the potential benefits against the risks, but hydroxyzine has specific contraindications that outweigh potential benefits in most scenarios 1, 2