Sudafed and Pregnancy
Clinical studies on pregnancy and Sudafed (pseudoephedrine) show that taking the drug during early pregnancy can increase the risk of gastroschisis or small intestinal atresia. Due to this potential risk, Sudafed has been classified as a pregnancy Category C medicine by the FDA. If you are taking this medication and pregnancy occurs, contact your healthcare provider to discuss the benefits and risks.
Sudafed® (pseudoephedrine hydrochloride) is a decongestant often used for allergies or the common cold. This medication may not be safe for use during pregnancy, although the full risks are not currently known.
(The information in this article applies to original Sudafed, now found behind the pharmacy counter. For information about the reformulated Sudafed products that do contain phenylephrine instead of pseudoephedrine, see Sudafed PE and Pregnancy.)
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
There is some preliminary evidence that taking this drug in early pregnancy (during the first trimester) may increase the risk of gastroschisis (an opening in the abdominal wall which allows a portion of the intestines to protrude) or small intestinal atresia (a blockage or missing section of the small intestine). However, the risk (if it truly exists) appears to be small and other causes (such as other medications) cannot be ruled out.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to pregnant women if a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.