Study Links Decongestants Like Sudafed to an Increase in Birth Defects

A study published earlier this month in the American Journal of Epidemiology shows a strong correlation between birth defects and the consumption of Sudafed and similar over-the-counter medications during pregnancy.

Researchers conducting this study have determined that exposure to phenylephrine, as well as pseudoephedrine, the active ingredients in Sudafed, if taken during the first trimester of pregnancy, may pose a risk of children developing heart, ear, and even digestive deformities or defects.

“Major birth defects of any kind affect about two to three percent of live-born infants, so they are rare,” said Dr. Allen Mitchell, author of the study and director of the Slone Epidemiology Center at Boston University. “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.”  He followed with a disclaimer, which stated that, as decongestants are among the most widely-used drugs, a full understanding of the consequences and side effects is important.

The study was conducted after a previous Birth Defects Study from the Slone Epidemiology Center suggested that decongestants were linked to birth defects among babies whose mothers took the decongestants during the first trimester. That report also suggested a link between an increased risk of cleft palate, eye defects, and clubbed foot; however, those links were not at discussion in the study that just concluded.

The Birth Defect Study found a total of 12,734 births involved birth defects or malformations in the United States and Canada, with 7,606 controls, or infants without deformities.  Use of phenylephrine during the first trimester of pregnancy is linked to an eight-times higher risk of a heart defect, called endocardial cushion defect. In addition, use of phenylpropanolamine (Acutrim) was also linked to an eight-times higher risk of defects of the ear and stomach.  Both of these links were suggested by the earlier study. However, what was not discussed in the earlier study is a link between first-trimester use of pseudephedrine and a three-times higher risk of limb reduction defects.

Dr. Mitchell said that, “the risks we identified should be kept in perspective. The risk of endocardial cushion defect among babies whose mothers did not take decongestants is about 3 per 10,000 live births.”

While an eight-times increase sounds scary, it is not that big of an increase, when put in perspective. For instance, an eight-fold increase only equates to a 2.7 in 1,000 chance the baby would have a defect, according to Dr. Mitchell.

Marleen van Gelder, an epidemiologist at Radboud University Nijmegen Medical Center in the Netherlands, lent some encouraging words. “Since the absolute risks for these rare birth defects are still very small, pregnant women should not be very worried after having used these drugs.” She added, “it should always be determined whether the beneficial effects of treatment outweigh the possible risks for the developing fetus.”

Dr. Mitchell recognized the fact that decongestants are widely available as an over-the-counter remedy. However, just because they can be purchased without the approval of a healthcare provider, does not necessarily make them safe to consume with respect to the fetus, since there are still very few studies done on the correlation.

What do you think about this study? Will you take Sudafed during your first trimester, or do they need to reveal more information before you take any action? Feel free to comment on this blog post. For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).

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