Researchers at the Slone Epidemiology Center at Boston University recently looked at the use of common over-the-counter decongestants by pregnant women. Using a large collection of data on babies born with birth defects collected between 1993 and 2010, researchers interviewed the mothers of babies with birth defects not caused by chromosome problems and analyzed the results. This data was compared with similar data from the mothers of babies without birth defects.
During the interviews, mothers were asked about medications they took while pregnant and in the two months before they became pregnant. Specifically, researchers looked at the use of phenylephrine (found in Sudafed PE or Neo-Synephrine) and pseudoephedrine (aka Sudafed.) They found that these two common decongestants were individually linked to rare, specific birth defects of the heart and limbs.
"Major birth defects of any kind affect about two to three percent of liveborn infants, so they are rare," said study author Dr. Allen Mitchell, director of the Slone Epidemiology Center. "The associations we identified involved defects that generally affect less than 1 per 1,000 infants. Some of them may require surgery, but not all are life-threatening."
First-trimester use of phenylephrine was linked to an eight-fold higher risk of a heart defect called endocardial cushion defect. Use of pseudoephedrine was tied to a 3-fold higher risk of limb reduction defects, or when one or more of a baby's limbs fails to form completely.
"The risks we identified should be kept in perspective," Mitchell cautioned. "The risk of an endocardial cushion defect among babies whose mothers did not take decongestants is about 3 per 10,000 live births."
Thus, while an eight-fold increase in risk sounds scary, it still only translates to a 2.7 in 1,000 chance that the baby would have the birth defect.
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