Sudafed, Nasal Decongestants Linked to Birth Defects: Study

New research suggests that potential side effects of Sudafed and other common cold medications could pose a risk of birth defects if the over-the-counter medications are used by pregnant women.

In a study published this month in the American Journal of Epidemiology, researchers found that exposure to decongestants containing phenylephrine and pseudoephedrine (the active ingredients in Sudafed) during the first trimester of pregnancy may pose a risk of children developing defects or malformations involving the heart, ear or digestive system.

Researchers looked at data from the Slone Epidemiology Center birth Defects Study from 1993 through 2010. From the data examined, a total of 12,734 births involving defects or malformations were identified in the U.S. and Canada, with 7,606 controls.

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The study found that pseudoephedrine use was associated with three times the risk of limb reduction defects. Phenylephrine use was linked to an eight-fold increased risk of heart defects, and the active ingredient in Acutrim (phenylpropanolamine) was linked to eight times the risk of ear and stomach defects.

The researchers note that even the largest increases only result in a small number of birth defects, about 2.7 per 1,000 births. That compares to about 3 per 10,000 births when it comes to endocardial cushion defects, the defects associated with phenylephrine.

The study was based on some previous reports linking decongestants to birth defects. While it appeared to confirm some of the links, others, such as links to increased risk of cleft palate, eye defects and club foot were not seen by the study.


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