NMA: Nonprescription Medicines Academy

Oral, Nasal Decongestants May Increase Risk of Birth Defects

August 22nd, 2013

A woman’s use of specific oral and possibly intranasal decongestants during the first trimester of pregnancy may raise her child’s risk of certain rare birth defects, according to data from the Slone Epidemiology Center Birth Defects Study (BDS).

The analysis included data from the period January 1993 to January 2010 for 12,734 infants with malformations (cases) and 7,606 control infants in the United States and Canada. Among mothers of malformed infants, 656 (8.6%) reported use of one or more oral or intranasal decongestants during the first trimester; 592 (7.8%) had used an oral product, and 92 (1.2%) had used an intranasal product. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated for specific birth defects, with controlling for potential confounders.

The results supported a number of previously hypothesized associations. First-trimester use of phenylephrine was associated with an eight-fold higher risk of endocardial cushion defect (4 exposed cases; OR, 8.0; 95% CI, 2.5–25.3). Use of phenylpropanolamine was associated with an eight-fold risk of ear defects (4 exposed cases; OR, 7.8; 95% CI, 2.2–27.2) and a three-fold increase in pyloric stenosis (6 exposed cases; OR, 3.2; 95% CI, 1.1–8.8).

The results also revealed several associations not previously hypothesized. First-trimester use of pseudoephedrine was associated with an increase in risk for limb reduction defects (OR, 2.4; 95% CI, 1.5–3.7). An increased risk of pyloric stenosis was found for first-trimester use of any intranasal decongestant (OR, 1.9; 95% CI, 1.0–3.5) and for imidazoline derivatives specifically (OR, 2.2; 95% CI, 1.1–4.5). Use of imidazolines also was associated with an increase in risk for tracheoesophageal fistula (OR, 3.3; 95% CI, 1.2–8.9). Second-trimester exposure to oxymetazoline was associated with renal collecting system anomalies (OR, 3.1; 95% CI, 1.3–6.9).

Am J Epidemiol. 2013 Jul 15;178(2):198-208.