Dymista and Pregnancy
When the active ingredients in Dymista (azelastine/fluticasone nasal spray) were given to pregnant animals, it increased the risk for miscarriage, birth defects, and other problems in the fetus. As a result, this drug is classified as a pregnancy Category C medication. This means that women may not be able to use Dymista during pregnancy, unless the benefits to the mother outweigh the potential risks to the child.
Can Pregnant Women Use Dymista?Dymista™ (azelastine/fluticasone nasal spray) is a prescription medication approved to treat seasonal nasal allergy symptoms. It contains two different medications: a corticosteroid (fluticasone) and an antihistamine (azelastine). Animal studies have shown that corticosteroids can increase the risk for 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. Dymista 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.
Both of the individual active ingredients in Dymista are pregnancy Category C medications. Fluticasone was given a pregnancy Category C classification because it is a corticosteroid. When given to pregnant animals, corticosteroids can increase the risk for problems, including birth defects (such as cleft palate), low fetal weight, and slow bone development.
Azelastine was also given a pregnancy Category C rating because of problems seen in animal studies. When given to pregnant mice, extremely large doses increased the risk for miscarriages, birth defects (including cleft palate and missing tails or ribs), and low fetal weight. Similar results were seen in rats and 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, including Dymista, 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.