Rhinocort Aqua and Pregnancy
In clinical studies on Rhinocort Aqua and pregnancy, the medicine caused miscarriages, bone defects, and low birth weight when it was given to pregnant animals. Since studies have not shown the same risk in humans, healthcare providers can prescribe the drug to pregnant women if the benefits outweigh the risks. If you are taking Rhinocort Aqua and pregnancy occurs, contact your healthcare provider right away.
Rhinocort Aqua® (budesonide nasal spray) is a prescription medication approved to treat nasal allergies in adults and children as young as six years old. It belongs to a group of medications known as corticosteroids. Animal studies have shown that corticosteroids can increase the risk of problems during pregnancy, including birth defects. However, studies suggest that Rhinocort Aqua is probably safe for use by pregnant women.
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 B is given to medicines that have not been extensively studied in pregnant humans but that do not appear to cause harm to the fetus in animal studies. It is also given to medications that seem to cause problems in pregnant animals but have been shown to be safe in human studies.
Rhinocort Aqua was given a pregnancy Category B classification because it has been studied in pregnant women without causing problems, although animal studies suggested that it may not be safe during pregnancy. In other words, it does not appear to be safe in animals, but studies have not shown that same risk in humans. In animals, Rhinocort Aqua increased the risk of miscarriages, low birth weight, and bone defects.
However, it is important to note that while human studies did not suggest problems with Rhinocort Aqua, these studies could not completely rule out the possibility of problems. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.