Hydroxyzine (Vistaril) Use During Pregnancy
Hydroxyzine is contraindicated during early pregnancy due to inadequate safety data in humans and evidence of fetal abnormalities in animal studies at high doses. 1
Safety Classification and Concerns
- Hydroxyzine is classified as FDA Pregnancy Category C, meaning animal studies have shown adverse effects on the fetus, but there are no adequate studies in humans 2
- The FDA drug label explicitly states that hydroxyzine is contraindicated in early pregnancy 1
- Animal studies have demonstrated fetal abnormalities in rats and mice when hydroxyzine was administered at doses substantially above the human therapeutic range 1
Risk Assessment
The decision to use any medication during pregnancy requires careful consideration of:
- Maternal benefit: The severity of symptoms requiring treatment
- Fetal risk: The potential harm to the developing fetus
- Alternative options: Safer medications available for the same indication
Specific Risks of Hydroxyzine
- Hydroxyzine crosses the placental barrier and may affect the developing fetus
- The drug label clearly states that clinical data in humans are inadequate to establish safety in early pregnancy 1
- Hydroxyzine is also contraindicated in patients with prolonged QT interval, which can be a concern during pregnancy 1
Alternative Treatment Options
For conditions typically treated with hydroxyzine (anxiety, pruritus, nausea):
For Allergic Conditions:
- First choice: Cetirizine or loratadine (Category B antihistamines) have better safety profiles during pregnancy 2
- Intranasal corticosteroids may be used for allergic rhinitis symptoms during pregnancy when benefits outweigh risks 2
For Anxiety:
- Consider non-pharmacological approaches first (cognitive behavioral therapy, relaxation techniques)
- If medication is necessary, SSRIs like sertraline have established safety profiles in pregnancy 3
Clinical Approach
- Avoid hydroxyzine in the first trimester completely due to explicit contraindication
- Consider safer alternatives for the specific indication
- Document the rationale for any treatment decision during pregnancy
- Monitor closely if hydroxyzine must be used in later pregnancy (only if benefits clearly outweigh risks)
Important Considerations
- The safety of medications during pregnancy is often based on limited data
- The FDA pregnancy category system provides general guidance but has limitations
- The contraindication in the official drug label represents the strongest level of warning against use during pregnancy
- Always weigh maternal benefit against potential fetal risk when considering any medication during pregnancy
Remember that untreated maternal conditions can also pose risks to both mother and fetus, so appropriate alternative treatments should be considered rather than simply discontinuing medication.