Dexamethasone and Pregnancy
Based on both animal studies and observational studies, the Food and Drug Administration considers dexamethasone a pregnancy Category C medication. Some sources also consider it a pregnancy Category D drug if used during the first trimester. It does carry a clear risk of cleft palate, cleft lip, and other birth defects, so the medication should be avoided if at all possible in women who are expecting.
Can Pregnant Women Take Dexamethasone?Dexamethasone is a prescription medication in the class of drugs known as corticosteroids, or just "steroids" for short. Based on the results of animal studies, this drug may not be safe for use during pregnancy.
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 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.
When given to pregnant mice, rats, and rabbits, corticosteroids like dexamethasone increased the risk of cleft palate in the offspring. Dexamethasone caused cleft palate in the offspring when applied to the eyes of pregnant mice, and it caused multiple birth defects when applied to the eyes of pregnant rabbits.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Large observational studies suggest an association between corticosteroid use and specific birth defects. In these studies, women who had babies born with cleft palate or cleft lip were more likely to be taking oral corticosteroids (including dexamethasone) than women who had babies without birth defects.
Some sources consider dexamethasone a pregnancy Category D medication when used in the first trimester. Pregnancy Category D is given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. Like a Category C medicine, a pregnancy Category D medicine may still be given to a pregnant woman if the benefits to the woman outweigh the possible risks to the developing baby.