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Decongestant Use in Pregnancy Linked to Birth Defects

Authors find small but worrying risk (July 22)

According to a study published in the American Journal of Epidemiology, a woman’s use of decongestant medications in the first trimester of pregnancy may increase her child’s risk of developing certain rare birth defects.

Some over-the-counter decongestants, including phenylephrine (found in Sudafed [McNeil]), among other products) and pseudoephedrine (also in Sudafed) were individually linked to birth defects of the heart, ear, and digestive tract.

Using epidemiology data from January 1993 to January 2010, researchers explored the hypothesis that exposure to specific oral decongestants increases the risk of birth defects. The data involved 12,734 infants with malformations (cases) and 7,606 non-malformed control infants in the U.S. and Canada.

The findings supported three previously reported associations: phenylephrine and endocardial cushion defect (odds ratio [OR] = 8.0; four exposed cases); phenylpropanolamine and ear defects (OR = 7.8; four exposed cases), and phenylpropanolamine and pyloric stenosis (OR = 3.2; six exposed cases). In addition, the use of imidazolines (found in nasal decongestant sprays and eye drops) was tied to an approximate doubling of the risk for an abnormal connection between the trachea and esophagus.

These risks, however, should be kept in perspective, the authors caution. For example, the eight-fold increased risk of an endocardial cushion defect translates to about 3 per 10,000 live births.

Nevertheless, the authors feel that physicians should not routinely recommend the use of decongestants in pregnant patients, but should evaluate each woman’s need for the drugs on a case-by-case basis.

Sources: Reuters; July 22, 2013; and AJE; July 16, 2013.

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