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 b2-agonists compared with nonchromosomal control registrations. Odds of exposure to salbutamol were similar. Nonsignificant ORs of exposure to inhaled b2-agonists were found for spina bifida, cleft lip, anal atresia, severe congenital heartdefects 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). Exploratoryanalyses found an association between renal dysplasia and exposure to the combination of long-acting b2-agonists and inhaled corticosteroids (OR, 3.95; 95% CI, 1.99-7.85).
Conclusions: The study confirmed increased odds of firsttrimester exposure to inhaled b2-agonists for cleft palate andgastroschisis and found a potential new signal for renal dysplasia associated with combined long-acting b2-agonists and inhaled corticosteroids. Use of inhaled corticosteroids duringthe first trimester of pregnancy seems to be safe in relation to the risk for a range of specific major congenital anomalies.
- Asthma medication
- congenital anomalies
- first trimester exposure
- inhaled b2-agonists
- inhaled corticosteroids