Women who take nasal decongestants in the first trimester of their pregnancy may be raising the risk that their newborn will suffer from one or more rare birth defects, according to a new study. Researchers at the Slone Epidemiology Center at Boston University found that phenylephrine, which is used in Sudafed, is associated with an eightfold increased risk of a heart deficiency called endocardial cushion defect when used in the first trimester of pregnancy. Acutrim, which contains phenylpropanolamine, was also linked to an eightfold-higher risk of ear and stomach defects. These findings confirmed suggestions made in prior studies, according to published reports.
Some of this study’s new findings are that there is a threefold increased risk of limb reduction defects associated with first-trimester use of pseudophedrine, another Sudafed ingredient, according to Reuters. In addition, imidazolines, which is used in nasal decongestant sprays and eye drops, was linked to a twofold increased risk of a defect that causes an abnormal connection between the trachea and the esophagus.
Study Analyzed Data from Nearly 13,000 Infants Born with Non-Chromosomal Defects
Dr. Allen Mitchell, director of the Slone Epidemiology Center at Boston University and lead author of the study, told Reuters: “Major birth defects of any kind affect about two to three percent of live-born infants, so they are rare…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.”
The study analyzed data from 12,700 infants born with non-chromosomal birth defects between 1993 and 2010 compared to 7,600 infants without deformities. According to Mitchell, the research is enough for doctors to not prescribe nasal decongestants to women, but this should be determined on an individual basis. “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,” said Mitchell.
Nasal Decongestants and Potential Birth Injuries
Pseudoephedrine is found in Sudafed, Actifed, Claritin, Benadryl, Zyrtec, Allegra, and other products which are among the most commonly used decongestants. Even though federal restrictions limit access to pseudoephedrine, this restriction has led to the replacement of pseudoephedrine with phenylephrine (which is associated with risks as well) in some cough/cold preparations.
Birth Injuries Associated with Pseudoephedrine:
- Ventricular septal defect (a defect in the ventricular septum, which is the wall dividing the left and right ventricles of the heart)
- small-intestinal atresia/stenosis (a complete blockage or obstruction in the intestine)
- and limb-reduction defects
Phenylephrine is found in Sudafed and other products. Phenylephrine use increased after federal restrictions were put on pseudoephedrine; in addition, it belongs to the same class of substituted phenethylamines as fenfluramine and dexfenfluramine, which were associated with cardiac valvulopathy (a condition in which the heart valve becomes inflamed and stiff) in adult users.
Birth Injury associated with Phenylephrine:
- Endocardial cushion defect (a condition in which the walls separating all four chambers of the heart are poorly formed or absent).
Phenylpropanolamine was removed from the market in 2000–2001 due to the reported risk of hemorrhagic stroke in adults.
Birth Injuries Associated with Phenylpropanolamine:
- Ear defects
- Pyloric Stenosis (a condition in which a baby vomits forcefully and often – additional problems may follow, such as dehydration).
Imidazolines is found in nasal decongestant sprays and eye drops.
Birth Injury Associated with Imidazolines:
- Abnormal connection between the trachea and esophagus.
Whether any oral decongestants (pseudoephedrine, phenylephrine, and phenylpropanolamine) cross the placenta to exert any direct effect on the fetus is unknown.
Source: American Journal of Epidemiology; July 3, 2013 issue
Legal Help for Victims of Nasal Decongestant-Caused Birth Defects
If you or a loved one took a nasal decongestant during the first trimester of your pregnancy and gave birth to a child with non-chromosomal defects such as those mentioned above, you have valuable legal rights. Please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) to discuss your case with one of our lawyers today.