Zetonna and Pregnancy
When the active ingredient in Zetonna was given to pregnant rabbits, it increased the risk for miscarriage, cleft palate, and other problems in the fetus. Due to these and other potential risks, this drug is classified as a pregnancy Category C medication. This means Zetonna may not be safe for use during pregnancy, unless the benefits to the mother outweigh the potential risks to the child.
Can Pregnant Women Use Zetonna?Zetonna™ (ciclesonide) is a prescription medication approved to treat nasal allergies. It belongs to a group of medications known as corticosteroids. Animal studies have shown that corticosteroids can increase the risk of problems, including birth defects.
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 used during pregnancy. Zetonna is classified as a pregnancy Category C drug.
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm 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 rabbits, ciclesonide (the active ingredient in Zetonna) increased the risk for miscarriage, low birth weight, cleft palate, and bone or skin problems. These problems occurred even at relatively low doses. However, when ciclesonide was given to pregnant rats, no problems occurred, even at very high doses.
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, including Zetonna, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.