Use of asthma medication during pregnancy and risk of specific congenital anomalies: A European case-malformed control study

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• 作者：Ester Garne ; MD^a ; ^{Ester.garne@rsyd.dk" class="auth_mail" title="E-mail the corresponding author} ; Anne Vinkel Hansen ; MSc^a ; Joan Morris ; PhD^b ; Louise Zaupper ; MD^a ; Marie-Claude Addor ; MD^c ; Ingeborg Barisic ; PhD^d ; Miriam Gatt ; MD ; MSc^e ; Nathalie Lelong ; MSc^f ; Kari Klungsø ; yr ; MD ; PhD^g ; Mary O'Mahony ; MFPHMI^h ; Vera Nelen ; MDⁱ ; Amanda J. Neville ; BSc^j ; Anna Pierini ; BSc^k ; David Tucker ; MPH^l ; Hermien de Walle ; PhD^m ; Awi Wiesel ; MD ; MScⁿ ; Maria Loane ; PhD^o ; Helen Dolk ; PhD^o
• 关键词：Asthma medication ; congenital anomalies ; pregnancy ; first trimester exposure ; inhaled β2-agonists ; inhaled corticosteroids
• 刊名：Journal of Allergy and Clinical Immunology
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：136
• 期：6
• 页码：1496-1502.e7
• 全文大小：577 K

文摘

Pregnant women with asthma need to take medication during pregnancy.

Objective

We sought to identify whether there is an increased risk of specific congenital anomalies after exposure to antiasthma medication in the first trimester of pregnancy.

Methods

We performed a population-based case-malformed control study testing signals identified in a literature review. Odds ratios (ORs) of exposure to the main groups of asthma medication were calculated for each of the 10 signal anomalies compared with registrations with nonchromosomal, nonsignal anomalies as control registrations. In addition, exploratory analyses were done for each nonsignal anomaly. The data set included 76,249 registrations of congenital anomalies from 13 EUROmediCAT registries.

Results

Cleft palate (OR, 1.63; 95% CI, 1.05-2.52) and gastroschisis (OR, 1.89; 95% CI, 1.12-3.20) had significantly increased odds of exposure to first-trimester use of inhaled β₂-agonists compared with nonchromosomal control registrations. Odds of exposure to salbutamol were similar. Nonsignificant ORs of exposure to inhaled β₂-agonists were found for spina bifida, cleft lip, anal atresia, severe congenital heart defects in general, or tetralogy of Fallot. None of the 4 literature signals of exposure to inhaled steroids were confirmed (cleft palate, cleft lip, anal atresia, and hypospadias). Exploratory analyses found an association between renal dysplasia and exposure to the combination of long-acting β₂-agonists and inhaled corticosteroids (OR, 3.95; 95% CI, 1.99-7.85).

Conclusions

The study confirmed increased odds of first-trimester exposure to inhaled β₂-agonists for cleft palate and gastroschisis and found a potential new signal for renal dysplasia associated with combined long-acting β₂-agonists and inhaled corticosteroids. Use of inhaled corticosteroids during the first trimester of pregnancy seems to be safe in relation to the risk for a range of specific major congenital anomalies.