Is hydroxyzine (an antihistamine) safe for anxiety during pregnancy?

Hydroxyzine Safety During Pregnancy for Anxiety

Hydroxyzine is contraindicated in early pregnancy and should not be used for anxiety during pregnancy due to safety concerns. 1

Safety Profile and Contraindications

Hydroxyzine has significant safety concerns during pregnancy:

• The FDA drug label explicitly states that hydroxyzine is contraindicated in early pregnancy 1
• Animal studies have shown fetal abnormalities in rats and mice at doses above the human therapeutic range 1
• Clinical data in humans are inadequate to establish safety in early pregnancy 1
• Hydroxyzine has been associated with neonatal withdrawal symptoms including tremors, irritability, hyperactivity, jitteriness, shrill cry, myoclonic jerks, hypotonia, increased respiratory and heart rates, feeding problems, and clonic movements 2

Alternative Treatment Options

For pregnant women requiring treatment for anxiety:

First-line non-pharmacological approaches:

• Cognitive-behavioral therapy should be employed whenever possible 3
• Environmental stress reduction techniques

Safer pharmacological alternatives if medication is necessary:

• Chlorpheniramine is considered safer during pregnancy with an excellent safety record and no significant increase in congenital malformations 4
• Second-generation antihistamines like loratadine and cetirizine have demonstrated safety through large birth registries 4
• For panic disorder specifically, SSRIs like sertraline or citalopram at low doses may be considered as they appear more favorable than other options 5

Monitoring Requirements

If a woman has been taking hydroxyzine and discovers she is pregnant:

• Discontinue the medication immediately
• Schedule level 2 ultrasonography to assess for any potential fetal abnormalities
• If hydroxyzine was used in the third trimester, newborns should be observed for 48-72 hours after birth for signs of withdrawal 4
• Inform pediatricians about maternal hydroxyzine use so they can monitor the newborn appropriately 4

Important Considerations

• The risk-benefit profile must be carefully evaluated, as untreated anxiety disorders can also negatively impact pregnancy outcomes 5
• A 1997 prospective controlled study of hydroxyzine in pregnancy did not find significant differences in pregnancy outcomes or malformation rates 6, but this single study does not override the FDA contraindication and other safety concerns
• The FDA contraindication 1 and evidence of neonatal withdrawal symptoms 2 outweigh the limited reassuring data

Clinical Decision Algorithm

1. For pregnant women with anxiety:

   • First attempt non-pharmacological approaches (CBT, stress reduction)
   • If medication is necessary, avoid hydroxyzine
   • Consider chlorpheniramine, loratadine, or cetirizine as safer antihistamine options
   • For severe anxiety disorders, consult with psychiatry for consideration of safer alternatives

2. For women already taking hydroxyzine who become pregnant:

   • Discontinue hydroxyzine immediately
   • Schedule appropriate monitoring
   • Consider transition to safer alternatives if treatment remains necessary