Nasalide and Pregnancy

In animal studies on Nasalide and pregnancy, the medication increased the risk of birth defects and miscarriages when it was given to pregnant rats and rabbits. Since the drug has not been studied in pregnant women, however, it is not known whether similar problems are likely to occur in humans. If you are taking Nasalide and pregnancy occurs, notify your healthcare provider immediately.

 

Nasalide and Pregnancy: An Overview

Nasalide® (flunisolide nasal solution) is a prescription nasal spray licensed to treat nasal allergies (also known as allergic rhinitis) in adults and children as young as six years old. It belongs to a group of medications known as nasal corticosteroids (or simply "nasal steroids" for short). As with many other corticosteroids, animal studies have shown that the drug can increase the risk for birth defects and miscarriages.
 

Nasalide and 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 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.
 
Nasalide was assigned a pregnancy Category C classification due to problems in animal studies. When given to rats and rabbits, flunisolide (the active ingredient in Nasalide) increased the risk of birth defects and miscarriages. The medication has not been adequately studied in any pregnant women, so it is not known whether similar problems are likely to occur.
 
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.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;