Delsym and Pregnancy
The U.S. Food and Drug Administration has classified Delsym (dextromethorphan polistirex) as a pregnancy Category C medication, which means it may not be safe for pregnant women to use this cough suppressant. Some animal studies indicated that the drug might increase the risk of birth defects. However, this may not necessarily apply to humans, and the medicine may be prescribed if the benefits outweigh the risks.
Delsym® (dextromethorphan polistirex) is a nonprescription medication approved to treat coughing. At this time, it is not yet clear if this drug is safe for use during pregnancy, although several sources consider it acceptable for use in pregnant women.
What Is Pregnancy Category C?
The U.S. Food and Drug Administration (FDA) uses a 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.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Delsym was given a pregnancy Category C rating because animal studies suggest potential problems. Specifically, studies of dextromethorphan (the active ingredient in Delsym) in chick embryos showed that the drug increased the risk of birth defects.
However, this study has been criticized, as the doses used were high enough to be lethal to the embryos and, therefore, none actually hatched. Also, studies of chick embryos may not necessarily apply to humans.
Several survey-type studies suggest that dextromethorphan does not increase the risk of problems when taken during pregnancy. While these survey studies are reassuring, they are not adequate to rule out the possibility of rare problems.
It is important to note that a pregnancy Category C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.