A new worry for pregnant women to add to their list may be the use of decongestants, after the publication of new research in the American Journal of Epidemiology. Researchers have found possible links between using over-the-counter decongestants during the first trimester and birth defects in the digestive tract, ear and heart – albeit these are rare defects.

The research team, led by Dr. Allen Mitchell, used data spanning 17 years from the Slone Epidemiology Center Birth Defects Study at Boston University. Analyzing 12,734 malformed infants and 7,606 nonmalformed control infants, the team embarked upon the first study to investigate risks of intranasal decongestants during pregnancy.

By interviewing mothers of babies with and without birth defects, nurses recorded answers about first-trimester decongestant use, which Mitchell and his team analyzed.

The authors note that decongestants, particularly pseudoephedrine, are the most commonly used over-the-counter (OTC) medications during pregnancy. Though they found some risks involved with taking decongestants while pregnant, they suggest that their findings should be kept in perspective:

As one example, the baseline prevalence of endocardial cushion defect is about 0.34 per 1,000 live births; thus, even if phenylephrine exposure increased the risk eight-fold, the absolute risk of having an affected child still would be small (about 2.7 per 1,000 births; i.e., 0.27%).”

The researchers found the following relative increases in small absolute risks:

  • Use of phenylephrine (in Sudafed) is linked to an eight-fold increase in risk for endocardial cushion defect (heart)
  • Use of phenylpropanolamine (in Acutrim) is likewise linked to an eight-fold increase in risk for defects of the ear and stomach
  • Use of Pseudoephedrine (in Sudafed) is linked to a 3-fold increase in risk for limb reduction defects
  • Use of imidazolines (in nasal sprays and eye drops) is linked to a 2-fold increase in risk for abnormal connections between the trachea and esophagus.

The researchers did not find a link between the medications and other deformities that previous studies have suggested, such as clubfoot or eye and face defects.

Since many of these decongestants are available as OTC drugs, Dr. Mitchell warns that pregnant woman may assume they are safe to use. He told Reuters:

The fact that medications such as decongestants are typically and widely available for use without a prescription and do not require consultation with a healthcare provider should not be assumed to mean they are safe with respect to the fetus, since there are still relatively few studies that examine the risks and relative safety of these ‘over-the-counter’ medications, which are more widely used in pregnancy than prescription medications.”

Dr. Mitchell’s study paper calls for his findings to be kept in perspective, however – and calls for more research. “Given the widespread use of decongestants by pregnant women,” the study concludes, “there is continuing need to obtain further data on the risks and relative safety of specific decongestants in relation to the wide range of specific birth defects.”