Astelin and Pregnancy
In clinical studies on Astelin and pregnancy, the medicine increased the risk of miscarriages, birth defects, and low fetal weight when it was given to pregnant animals. However, animals do not always respond to drugs in the same way as humans. As a result, healthcare providers can prescribe Astelin to a pregnant woman if the benefits outweigh any possible risks.
Astelin® (azelastine hydrochloride) is a prescription medication approved to treat nasal allergies and nasal symptoms caused by irritants. It is part of a group of medications known as antihistamines. Animal studies have shown that the drug can increase the risk of miscarriages, birth defects, and other problems.
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.
Astelin was given this rating because of problems seen in animal studies. When given to pregnant mice, the drug increased the risk of miscarriages, birth defects (including cleft palate and missing tails or ribs), and low fetal weight. Similar results were seen in rats and rabbits. Astelin has not been studied in pregnant women.
However, 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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.