• About Us
    • Contact Us
    • Login
    • ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
About Us Contact Us Login ObGFirst
  • COVID-19
  • Alerts
  • OB
  • 2T US Atlas
  • The Genome
  • GYN
    • GYN
    • Sexual Health
  • Primary Care
  • Your Practice
  • GrandRounds
  • My Bookshelf
  • Now@ObG
  • Media
Grand Rounds

Fexofenadine Use in Pregnancy: Registry Cohort Study Results

image_pdfFavoriteLoadingFavorite

BACKGROUND AND PURPOSE:

  • Fexofenadine hydrochloride (trade name Allegra Allergy)
    • H1-receptor antagonist | Over the counter
    • Indicated for relief of symptoms associated with seasonal allergic rhinitis
  • Cetirizine hydrochloride (trade name Zyrtec Allergy) and loratadine ( trade name Claritin) are recommended as first-line choice of second-generation antihistamines for use during pregnancy by multiple US and international associations
  • Andersson et al. (JAMA Pediatrics, 2020) investigated whether fexofenadine use during pregnancy is associated with an increased risk for adverse fetal outcomes

METHODS:

  • Nationwide registry-based cohort study
  • Participants
    • Pregnancies in Denmark (January 1, 2001 to December 31, 2016)
  • Exposures
    • Filled prescription for fexofenadine
  • Study design
    • Pregnancy use of fexofenadine hydrochloride vs cetirizine hydrochloride use were compared
    • Fexofenadine and cetirizine were matched in a 1:1 ratio
    • Sensitivity analyses performed, comparing pregnancies with vs without fexofenadine exposure
    • Also compared fexofenadine exposure with
      • Previous fexofenadine use before pregnancy
      • Loratadine use during pregnancy
  • Statistical analysis
    • Logistic regression used to estimate prevalence odds ratios (ORs) of major birth defects, preterm birth, and SGA
    • Cox proportional hazards regression was used to estimate hazard ratios (HRs) of spontaneous abortion and stillbirth
  • Primary outcomes
    • Major birth defects
    • Spontaneous abortion
  • Secondary outcomes
    • Preterm birth
    • SGA
    • Stillbirth

RESULTS:

  • 1,287,668 pregnancies
    • Fexofenadine use: 2962 pregnancies
      • Mean (SD) age for analyses of major birth defects: 30.6 (4.8) years
      • Mean (SD) age for analyses of spontaneous abortion: 30.4 (5.5) years
    • Cetirizine use: 4901 pregnancies
  • Fexofenadine use was not associated with an increased risk of major birth defects compared to cetirizine
    • Fexofenadine use: 4.0% (118 pregnancies)
    • Cetirizine use: 3.8% (112 pregnancies)
    • OR 1.06 (95% CI 0.81 to 1.37)
  • Fexofenadine use during pregnancy was not associated with an increased risk of spontaneous abortion compared to cetirizine
    • Fexofenadine use: 8.4% (413 pregnancies)
    • Cetirizine use: 9.0% (439 pregnancies)
    • HR 0.93 (95% CI 0.82 to 1.07)
  • Fexofenadine use was also not associated with an increased risk of the secondary outcomes
    • Preterm birth
      • Fexofenadine use: 7.5% (370 pregnancies)
      • Cetirizine use: 7.7% (382 pregnancies)
      • OR 0.97 (95% CI 0.83 to 1.12)
    • SGA
      • Fexofenadine use: 10.1% (515 pregnancies)
      • Cetirizine use: 10.2% (523 pregancies)
      • OR 0.98 (95% CI 0.87 to 1.12)
    • Stillbirth
      • Fexofenadine use: 0.3% (16 pregnancies)
      • Cetirizine use: 0.4% (24 pregnancies)
      • HR 0.67 (95% CI 0.36 to 1.27)
  • Sensitivity analyses showed similar results (no associations) including comparisons of fexofenadine exposure vs
    • Pregnancies with loratadine use
    • Pregnancies unexposed to fexofenadine during pregnancy but with prior fexofenadine use

CONCLUSION:

  • The results of this study did not demonstrate an increased risk of adverse fetal outcomes with fexofenadine use during pregnancy
  • The authors state

…we suggest that fexofenadine can be used as equally as the other recommended antihistamines during pregnancy

Learn More – Primary Sources:

Association Between Fexofenadine Use During Pregnancy and Fetal Outcomes

Now You Can Get ObG Clinical Research Summaries Direct to Your Phone, with ObGFirst

ObGFirst® – Try It Free! »

image_pdfFavoriteLoadingFavorite
< Previous
All Grand Rounds Posts
Next >

Related ObG Topics:

Ondansetron for Nausea During Pregnancy – Is There a Risk for Birth Defects?
Is Macrolide Antibiotic Use During Pregnancy Linked to Increased Risk of Congenital Malformations?
Do Antidepressants During Pregnancy Increase Autism Risk?
ACOG & SMFM: Acetaminophen Use and Safety in Pregnancy
Adverse Perinatal Outcomes and Epilepsy: Is it the Disorder or the Treatment?

Sections

  • COVID-19
  • Alerts
  • OB
  • GYN
    • GYN
    • Sexual Health
  • 2T US Atlas
  • The Genome
  • Primary Care
  • Your Practice
  • Grand Rounds
  • My Bookshelf
  • Now@ObG
  • Media

Are you an
ObG Insider?

Get specially curated clinical summaries delivered to your inbox every week for free

  • Site Map/
  • © ObG Project/
  • Terms and Conditions/
  • Privacy/
  • Contact Us/
© ObG Project
SSL Certificate


  • Already an ObGFirst Member?
    Welcome back

    Log In

    Want to sign up?
    Get guideline notifications
    CME Included

    Sign Up

Download Your ObG App
HERE!

Sign In

Lost your password?

Sign Up for ObGFirst and Stay Ahead

  • - Professional guideline notifications
  • - Daily summary of a clinically relevant
    research paper
  • - Includes 1 hour of CME every month

ObGFirst Free Trial

Already a Member of ObGFirst®?

Please log in to ObGFirst to access the 2T US Atlas

Password Trouble?

Not an ObGFirst® Member Yet?

  • - Access 2T US Atlas
  • - Guideline notifications
  • - Daily research paper summaries
  • - And lots more!
ObGFirst Free Trial

Media - Internet

Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Jointly provided by

NOT ENOUGH CME HOURS

It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan

Subscribe

JOIN OBGFIRST AND GET CME/CE CREDITS

One of the benefits of an ObGFirst subscription is the ability to earn CME/CE credits from the ObG entries you read. Tap the button to learn more about ObGFirst

Learn More
Leaving ObG Website

You are now leaving the ObG website and on your way to PRIORITY at UCSF, an independent website. Therefore, we are not responsible for the content or availability of this site