Astepro and Pregnancy
In studies on pregnancy and Astepro, the medication increased the risk of miscarriages, birth defects, and low fetal weight when it was given in high doses to pregnant animals. However, the low Astepro dosage used in humans seems unlikely to cause these problems. If you are using this medication and pregnancy occurs, be sure to talk to your healthcare provider about the potential risks.
Is Astepro During Pregnancy Safe?
Astepro™ (azelastine hydrochloride) is a prescription medication approved to treat seasonal and year-round nasal allergies. It is part of a group of medications known as antihistamines.
Animal studies have shown that very high doses of Astepro can increase the risk of miscarriages, birth defects, and other problems, although the low Astepro dosage used in humans is probably unlikely to cause such problems.
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 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.
Astepro was given a pregnancy Category C rating because of problems seen in animal studies. When given to pregnant mice, extremely large doses of Astepro 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.
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 pregnant woman outweigh any possible risks to the unborn child.
Astepro has not been studied in pregnant women. However, it is not expected that the much lower dosages will cause significant problems.