First-trimester antihistamine exposure and risk of spontaneous abortion or preterm birth

Tiara D. Aldridge, Katherine E. Hartmann, Kara A. Michels, Digna R. Velez Edwards

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


Purpose: We tested whether antihistamine exposure during early pregnancy is associated with spontaneous abortion (SAB) or preterm birth (PTB). Methods: Women were enrolled in Right from the Start (2004-2010), a prospective pregnancy cohort. Data about first-trimester antihistamine use were obtained from screening and first-trimester interviews. Self-reported outcomes included SAB and PTB and were verified by medical records. Cox proportional hazards models were used to test for an association between antihistamine use and each outcome, both performed adjusting for confounders. Results: Among the 2685 pregnancies analyzed, 14% (n=377) reported use of antihistamines. Among antihistamine users, 12% (n=44) experienced SABs, and 6% (n=21) had PTBs. Antihistamine exposure was not associated with SAB (adjusted hazard ratio [aHR]=0.88, 95% confidence interval [CI] 0.64, 1.21) or PTB, which was modified by maternal race (aHR=1.03, 95%CI 0.61, 1.72 among White women and aHR=0.43, 95%CI 0.14, 1.34 among Black women). Conclusions: Despite the biologic plausibility that antihistamine use may influence pregnancy outcomes, we did not detect evidence of an association with SAB or PTB. These data demonstrate the utility of large prospective cohorts for evaluating drug safety in pregnancy when concerns are raised from animal models.

Original languageEnglish
Pages (from-to)1043-1050
Number of pages8
JournalPharmacoepidemiology and Drug Safety
Issue number10
StatePublished - Oct 1 2014

Bibliographical note

Publisher Copyright:
© 2014 John Wiley & Sons, Ltd.


  • Histamine antagonists
  • Pharmacoepidemiology
  • Pregnancy
  • Prospective studies

ASJC Scopus subject areas

  • Epidemiology
  • Pharmacology (medical)


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