The fact that a medicine is available over-the-counter doesn't mean it's safe -- and this dictum holds especially true for pregnant women. New research confirms the link between taking certain oral and intranasal decongestants during the first trimester of pregnancy with certain rare birth defects of the heart, ears, and digestive tract.

None of the birth defects were life-threatening, and could be corrected with surgeries. But still, the conclusions suggest that it is far from safe to use drugs, like phenylephrine and psuedoephedrine both contained in Sudafed, during the early phases of pregnancy.

Led by Dr. Allen Mitchell, director of Slone Epidemiology Center at Boston University, nurses interviewed thousands of mothers of babies born with and without birth defects from 1993 to 2010. They collected information about medications taken during pregnancy and the months leading up to pregnancy for 12,734 infants with non-chromosomal deformities, and 7,606 infants without.

The Results: A Mix Of Old And New Findings

First trimester phenylephrine, found in Sudafed and similar nasal congestions, was associated with an eightfold increased risk of a heart defect known as endocardial cushion defect. This condition manifests as a failure of the walls of the chambers of the heart to close completely and requires surgery.

Another known association confirmed by the study is that between Phenylpropanolamine (Acutrim) and an eightfold increase in deformities of the ear and a threefold increase in risk for certain stomach defects. This drug could increase the risk for pyloric stenosis, a condition in which the area between the esophagus and the stomach is so constricted that digestion is nearly impossible without corrective surgery.

Among the newly discovered associations is one between pseudoephedrine, also contained in Sudafed, and a threefold increased risk of limb reduction defects, in which the limbs do not completely form in utero. Also imidazolines, found in nasal decongestant sprays and eye drops were connected to a doubled risk of tracheoesophageal fistula, a condition in which an abnormal connection between the trachea and esophagus. This may require several surgeries to fix.

Researchers note that the likelihood of any of these birth defects occuring is already very low. Usually 2-3 percent of liveborn infants are born with a major defect, and the incidence rate for some of these individual defects are low to begin with. And the associations uncovered in this study still have risks of affecting one in 1,000 births.

"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," Marleen van Gelder, an epidemiologist at Radboud University Nijmegen Medical Center in the Netherlands, told Reuters Health.

Reducing The Risk Of Birth Defects Due To Decongestants

Pregnant women and women hoping to get pregnant should take the effort to research the safety of drugs. An especially useful way to educate yourself is becoming familiar with the Pregnancy Category system used by the Food and Drug Administration. Drugs, over-the-counter and prescription, are labeled with different categories based on the risk it poses to fetuses and breastfeeding children.

Similarly, healthcare providers should probably refrain from recommending that pregnant women take any kind of decongestant. These decisions should be made on an individual basis, since a nasty sinus infection, left untreated, could have even more harmful effects on a woman and a fetus if the infection were to travel through the bloodstream.

For the run-of-the-mill sinus infection or seasonal rhinitis, pregnant women could relieve their symptoms in a number of simple yet effective ways. Using a neti pot or saline irrigation system to wash out the sinuses with warm saline water can help eliminate purulent drainage. A combination of inhaling steamy air and massaging the area around the cheeks and sinuses with the fingertips could help break up and expel mucous. A number of ingestible herbal remedies exist too, but even less research exists on the safety of these for pregnant women, and should be treated with caution.

Source: Yau WP, Mitchell AA, Lin KJ, Werler MM, Hernández-Díaz S. Use of decongestants during pregnancy and the risk of birth defects. Am J Epidemiol. 2013.