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Omnaris and Pregnancy
In animal studies on Omnaris and pregnancy, the medicine increased the risk of miscarriages, bone or skin problems, low birth weight, and cleft palate when it was given to pregnant rabbits. No problems occurred when it was given to pregnant rats, however. If you are using Omnaris and pregnancy occurs, your healthcare provider will weigh the benefits and risks in your particular situation.
Omnaris™ (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.
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 that 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.
When given to pregnant rabbits, Omnaris increased the risk of miscarriages, low birth weight, cleft palate, and bone or skin problems. These problems occurred even with relatively low doses of the drug. However, when Omnaris 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 the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD