Vistaril (Hydroxyzine) Should Not Be Used at 7 Months Pregnancy
Hydroxyzine is contraindicated in early pregnancy according to FDA labeling, and its use at 7 months (third trimester) should be avoided due to documented fetal risks and neonatal withdrawal syndrome. 1
FDA Contraindication and Fetal Risks
The FDA drug label explicitly states that hydroxyzine is contraindicated in early pregnancy because it induced fetal abnormalities in rats and mice at doses above the human therapeutic range, and clinical data in humans are inadequate to establish safety. 1
While the FDA contraindication specifically mentions "early pregnancy," the label's warning about inadequate human safety data extends concern throughout pregnancy. 1
A documented case report describes neonatal withdrawal syndrome in an infant whose mother took 600 mg daily of hydroxyzine throughout pregnancy, manifesting as irritability, tremors, and other withdrawal symptoms requiring medical management. 2
Guideline Recommendations Against Use
The Journal of Allergy and Clinical Immunology guidelines on rhinitis management do not recommend hydroxyzine during pregnancy, notably omitting it from pregnancy treatment algorithms while discussing other antihistamines. 3
The same guidelines note that although diphenhydramine (a similar first-generation antihistamine) is frequently used in pregnancy, it has been associated with cleft palate development, raising concerns about this entire drug class. 3
Safer Alternatives for Common Indications
If hydroxyzine was prescribed for anxiety or nausea:
- For nausea and vomiting in pregnancy, metoclopramide or ondansetron are considered safer alternatives according to European guidelines. 4
If hydroxyzine was prescribed for allergic conditions:
- Second-generation antihistamines like cetirizine or loratadine have better safety profiles in pregnancy (Category B). 3
- Cetirizine is actually the active metabolite of hydroxyzine but lacks the concerning fetal effects. 1
Critical Clinical Pitfalls
Do not assume over-the-counter availability equals safety in pregnancy - hydroxyzine's accessibility does not reflect its documented fetal risks. 5
High doses pose particular risk - the neonatal withdrawal case involved 600 mg daily, but no safe dose threshold has been established in pregnancy. 2
Third-trimester exposure carries specific concerns about neonatal adaptation syndrome, similar to other sedating medications. 2
Immediate Action Required
Discontinue hydroxyzine immediately and substitute with a pregnancy-compatible alternative based on the indication (anxiety, nausea, or allergies), consulting with obstetrics given the third-trimester timing. 1, 3