FDA approves revised labeling for anti-inflammatory corticosteroid nasal spray

Aug 26 2004

AstraZeneca has announced that the U.S. Food and Drug Administration has approved revised labeling for its anti-inflammatory corticosteroid nasal spray RHINOCORT AQUA® (budesonide).

The new labeling upgrades RHINOCORT AQUA's pregnancy rating to Category B for the treatment of allergic rhinitis.

The achievement of a Category B rating indicates that adequate studies in pregnant women have demonstrated that treatment with RHINOCORT AQUA does not increase the risk of congenital malformations to the fetus during the first trimester of pregnancy and in later trimesters. This may give physicians greater confidence in prescribing a particular medication for women of child-bearing age or during pregnancy.

The FDA's pregnancy category rating system provides guidance to help physicians who prescribe medications to pregnant women. RHINOCORT AQUA is the first and only intranasal corticosteroid product for the treatment of allergic rhinitis in the United States to receive a Category B rating. All other intranasal corticosteroids approved by the FDA for the treatment of allergic rhinitis are rated Pregnancy Category C.

"AstraZeneca is a committed leader in the research and development of respiratory therapies and we are pleased to share this important information about the relative safety of RHINOCORT AQUA when women who are pregnant use our product," said William Mezzanotte, MD, Executive Director, Clinical Research. "This revised labeling for RHINOCORT AQUA should provide reassurance to patients who are, or who may become pregnant, and also need to control symptoms of allergic rhinitis."

The FDA based its pregnancy category label change for RHINOCORT AQUA upon a review of data from three Swedish birth registries. These registries covered over 2,000 births from 1995-2001 (Swedish Medical Birth Registry, Registry of Congenital Malformations, and Child Cardiology Registry). The data indicate no increased risk for overall congenital malformation (birth defects), from the use of intranasal budesonide during early pregnancy. Early pregnancy is the period during which most major organ malformations can occur. This evidence demonstrates that intranasal and inhaled budesonide, the active compound in RHINOCORT AQUA, does not increase the risk of abnormalities when administered during pregnancy.

"Pregnant women suffering from significant symptoms of allergic rhinitis should be appropriately treated with medications that offer potential benefit and minimal risk," said Joan C. Gluck, MD, Partner, Florida Center for Allergy and Asthma Care, Miami, FL. "The change in pregnancy rating for RHINOCORT AQUA means that the medical community now has evidence of what to expect when pregnant women use this drug. Other drugs in this class have Category C ratings and they lack this evidence."

Experience in pregnant women has not shown that RHINOCORT AQUA increases the risk of fetal abnormalities when administered during pregnancy. Despite adverse effects in animal reproductive studies, it would appear that the possibility of fetal harm is remote (see PRECAUTIONS in full Prescribing Information). Nevertheless, because studies in humans cannot rule out the possibility of harm, RHINOCORT AQUA should be used in pregnancy only if clearly indicated.

It is not known whether budesonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when RHINOCORT AQUA Nasal Spray is administered to nursing women.

Commonly known as "hay fever," allergic rhinitis is a respiratory allergy that causes an inflammation or irritation of the mucous membranes lining the nose. It is caused by allergens such as pollen, dust mites, mold, or animal dander and may produce sneezing, congestion, runny nose, and other related symptoms. According to the American Academy of Allergy, Asthma and Immunology, nearly 36 million people in the United States suffer from allergic rhinitis. The disorder leads to more than 16.7 million patient visits to physicians each year, with estimated costs in the United States exceeding $6 billion.

According to the National Center for Health Statistics, more than 6 million women of childbearing ages suffer from allergic rhinitis.