MedicalResearch.com Interview with:
Anick Bérard PhD FISPE
Research chair FRQ-S on Medications and Pregnancy and
Director Réseau Québécois de recherche sur le médicament (RQRM) and
Professor, Research Chair on Medications, Pregnancy and Lactation
Faculty of Pharmacy,University of Montreal
and Director, Research Unit on Medications and Pregnancy
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Intranasal corticosteroid (Nasacort) use during pregnancy for the treatment of seasonal allergies has increased over the past decade. Nasacort is now available over the counter since October 2013 in the US and January 2015 in Canada. Given that seasonal allergies are prevalent during pregnancy and that a medication available over-the-counter is likely to be used frequently, we aimed to study the risk of using Nasacort during gestation. Furthermore, given the potential public health impact, the objectives of our study were to assess the safety of intranasal triamcinolone exposure during pregnancy on the occurrence of major congenital malformations, small-for-gestational-age (SGA) newborn, and spontaneous abortions.
Use of intranasal triamcinolone during the first trimester of pregnancy was not significantly associated with the risk of overall congenital malformations (OR 0.88, 95%CI 0.60-1.28; 31 exposed cases) compared to non-exposure; it was however associated with the risk of respiratory defects (OR 2.71, 95%CI 1.11-6.64; 5 exposed cases). This is important given that a medication given for the treatment of respiratory diseases is associated with respiratory defects in newborns.
Pregnancy exposure to intranasal triamcinolone was not significantly associated with the risk of spontaneous abortions (OR 1.04, 95%CI 0.76-1.43; 50 exposed cases). No association was found between 2nd or 3rd trimester exposure to intranasal triamcinolone and the risk of SGA (OR 1.06, 95%CI 0.79-1.43; 50 exposed cases).
MedicalResearch.com: What should clinicians and patients take away from your report?
- Allergic rhinitis is prevalent.
· Gestational intranasal triamcinolone (Nasacort) use increases the risk of respiratory defects but not spontaneous abortions or SGA.* Although intranasal triamcinolone (Nasacort) is available over the counter in the US and Canada, patients and health care providers have to be aware of the potential risk of respiratory defects when used during the first trimester of pregnancy. This study may help inform physicians and patients on the treatment of allergic rhinitis or seasonal allergies during gestation.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: This is the first study to show this increased risk. Although biological plausibility exists, these findings need to be replicated in other settings to rule out chance finding.
MedicalResearch.com: Is there anything else you would like to add?
Response: To our knowledge our study is the first to investigate the risk of adverse pregnancy outcome associated with Rhinocort exposure during pregnancy. In sensitivity analyses, we found that even if intranasal budesonide (Rhinocort) has a pregnancy category B, it was associated with the highest risk of major malformation; this was however non-statistically significant. Furthermore, intranasal budesonide (Nasacort) was associated with some of the highest risk of organ specific defects, including respiratory defects.
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Intranasal triamcinolone use during pregnancy and the risk of adverse pregnancy outcomes
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Anick Bérard PhD FISPE (2016). First Trimester Use of Nasacort Linked To Respiratory Defects in Newborns MedicalResearch.com