A Stuffy Nose — and a Baby in the Tummy

Decongestants during pregnancy linked to birth defects if meds taken in first trimester

/ Author:  / Reviewed by: Robert Carlson, M.D

(RxWiki News) Pregnancy can bring joy, but it can also bring various discomforts — especially if you get a cold while pregnant. Is there anything you can take for your sinuses while pregnant?

In addition to following your doctor's recommendations, what you should avoid taking may depend on how far along you are in your pregnancy.

A recent study found links between certain decongestants and birth defects in babies. But the increased risk for birth defects mostly exists when the medications are taken in the first trimester.

There did not appear to be an increased risk to the baby when decongestants were taken in the third trimester. Only one medication taken in the second trimester showed a possible risk.

"Ask your doctor about safe medications during pregnancy."

This study, led by Wai-Ping Yau, PhD, of the Harvard School of Public Health Department of Epidemiology, looked at the risks of taking decongestants while pregnant.

Decongestants are medications that help relieve stuffy noses and stopped-up sinuses.

The researchers reviewed the medical records for 20,340 babies born in the US or Canada between 1992 and 2010.

Of these, 12,734 had birth defects and 7,606 did not. Those with chromosomal disorders or inherited disorders were not included.

The babies' mothers had been interviewed within six months of giving birth and provided information regarding their medical history, lifestyle, diet and medications taken during pregnancy.

The researchers analyzed the results after taking into account the women's demographics (race/ethnicity, age, education), weight and lifestyle behaviors, such as alcohol consumption and smoking.

Then they looked for any associations between medications the women had taken and an increased risk of birth defects in the women's children.

The results showed a link between taking certain decongestants (oral and nasal) during the first trimester and birth defects in the babies.

Some of these links had already been known and were confirmed in this study. Others were newly found links.

Babies of mothers who took the medication phenylephrine during the first trimester were eight times more likely to have a heart defect called endocardial cushion.

Babies of mothers who took the medication phenylpropanolamine were found to have a risk eight times greater for ear defects and three times greater for a digestive defect called pyloric stenosis. 

Pyloric stenosis means the opening from the stomach to the small intestine is narrowed.

Previous findings linked taking phenylpropanolamine to eye defects, but this connection was not confirmed in this study.

The new links identified in this study related to several different kinds of decongestants, but these links need to be further tested in future studies.

Among the new links, the study showed that taking pseudoephedrine (such as Sudafed) during the first trimester appeared linked to a higher risk for limb defects.

Further, taking intranasal decongestants during the first trimester was also linked to pyloric stenosis, the digestive defect.

Women taking medications with the ingredient imidazoline during the first trimester appeared to have a higher risk of having a baby with a defect related to the connection between the trachea (wind pipe) and the esophagus (food tube).

The only medication that showed any increased risks when taken during the second trimester was oxymetazoline, which was linked to a higher risk in babies for renal (kidney) problems.

None of the medications taken during the third trimester were linked to the birth defects.

According to Ronald de la Peña, MD, an OB/GYN at Los Robles Hospital in Thousand Oaks, California, the bottom line is to talk with your doctor.

"Over-the-counter medications may pose some small risk to the pregnancy, and every medicine used in pregnancy should be discussed with a physician prior to use," Dr. de la Peña said.

"This study is an invitation to follow up on this retrospective population study as a means to shed stronger light on the risk associated with medication in pregnancy, especially the first trimester," he said.

"The limitations of the study are the patients' recall of use, and the extent that patients used the medication as instructed," Dr. de la Peña pointed out. "The statistical analysis controlled for many factors, but given the real world variables of how consistent or inconsistent medications are used, it seems prudent not to over validate the conclusions."

This study was published July 3 in the American Journal of Epidemiology.

The research was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National University of Singapore-Overseas Post-doctoral Fellowship.

Although the Harvard School of Public Health receives some funding from pharmaceutical companies (including those that may make decongestants), no specific company funds were used for this study.

One author owned stock in Johnson and Johnson, which makes decongestants, until August 2012.

Reviewed by: 
Review Date: 
July 23, 2013
Last Updated:
August 1, 2013