Anick Bérard1, Odile Sheehy2, Marie-Laure Kurzinger3, Juhaeri Juhaeri4. 1. Research Center, CHU Ste-Justine, Montreal, Quebec, Canada; Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada. Electronic address: anick.berard@umontreal.ca. 2. Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada. 3. Sanofi, R&D, Global Pharmacovigilance and Epidemiology, Paris, France. 4. Sanofi, R&D, Global Pharmacovigilance and Epidemiology, Bridgewater, NJ.
Abstract
BACKGROUND: Intranasal corticosteroid use during pregnancy has increased over the past decade. OBJECTIVE: We aim to estimate the safety of intranasal triamcinolone use during pregnancy, which was introduced for over-the-counter use in October 2013. METHODS: We designed a population-based prospective cohort study. From a cohort of 289,723 pregnancies in Montreal, Quebec, Canada, from 1998-2008, intranasal triamcinolone-exposed, other intranasal corticosteroid-exposed, and nonexposed women during the first trimester were studied for major congenital malformations (overall and organ specific) and spontaneous abortions and during the second/third trimesters for small-for-gestational age (SGA) newborns. The first trimester is the time window of interest for malformations and spontaneous abortion (organogenesis), and the second/third trimesters are the time windows of interest for SGA (fetal growth). Logistic regression model-based generalized estimating equations were used. RESULTS: Adjusting for potential confounders, use of intranasal triamcinolone during the first trimester of pregnancy was not significantly associated with the risk of overall congenital malformations (odds ratio [OR], 0.88; 95% CI, 0.60-1.28; 31 exposed cases) compared with nonexposure; however, it was associated with the risk of respiratory defects (OR, 2.71; 95% CI, 1.11-6.64; 5 exposed cases). Pregnancy exposure to intranasal triamcinolone was not significantly associated with the risk of spontaneous abortion (OR, 1.04; 95% CI, 0.76-1.43; 50 exposed cases). No association was found between second- or third-trimester exposure to intranasal triamcinolone and the risk of SGA (OR, 1.06; 95% CI, 0.79-1.43; 50 exposed cases). CONCLUSIONS: Maternal exposure to intranasal triamcinolone during pregnancy was not associated with the risk of SGA/spontaneous abortions/overall malformations. However, it has been shown to increase the risk of respiratory system defects. Chance finding cannot be ruled out.
BACKGROUND: Intranasal corticosteroid use during pregnancy has increased over the past decade. OBJECTIVE: We aim to estimate the safety of intranasal triamcinolone use during pregnancy, which was introduced for over-the-counter use in October 2013. METHODS: We designed a population-based prospective cohort study. From a cohort of 289,723 pregnancies in Montreal, Quebec, Canada, from 1998-2008, intranasal triamcinolone-exposed, other intranasal corticosteroid-exposed, and nonexposed women during the first trimester were studied for major congenital malformations (overall and organ specific) and spontaneous abortions and during the second/third trimesters for small-for-gestational age (SGA) newborns. The first trimester is the time window of interest for malformations and spontaneous abortion (organogenesis), and the second/third trimesters are the time windows of interest for SGA (fetal growth). Logistic regression model-based generalized estimating equations were used. RESULTS: Adjusting for potential confounders, use of intranasal triamcinolone during the first trimester of pregnancy was not significantly associated with the risk of overall congenital malformations (odds ratio [OR], 0.88; 95% CI, 0.60-1.28; 31 exposed cases) compared with nonexposure; however, it was associated with the risk of respiratory defects (OR, 2.71; 95% CI, 1.11-6.64; 5 exposed cases). Pregnancy exposure to intranasal triamcinolone was not significantly associated with the risk of spontaneous abortion (OR, 1.04; 95% CI, 0.76-1.43; 50 exposed cases). No association was found between second- or third-trimester exposure to intranasal triamcinolone and the risk of SGA (OR, 1.06; 95% CI, 0.79-1.43; 50 exposed cases). CONCLUSIONS: Maternal exposure to intranasal triamcinolone during pregnancy was not associated with the risk of SGA/spontaneous abortions/overall malformations. However, it has been shown to increase the risk of respiratory system defects. Chance finding cannot be ruled out.