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T98-79                         Print Media:         301-827-6252
November 9, 1998               
                               Consumer Inquiries:  888-463-6332

FDA REQUIRES NEW PEDIATRIC LABELING
FOR INHALED, INTRANASAL CORTICOSTEROIDS

FDA today informed companies of new pediatric information that will be required on the labeling of all orally inhaled and intranasal corticosteroids. The new labeling language will alert health care providers that using these drugs in children may reduce their rate of growth. It will also recommend using the lowest effective dose of these drugs and routinely monitoring patients' growth rates. The following information can be used to answer questions:

Controlled clinical studies have shown that inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. Growth velocity provides a means of comparing the rate of growth among children of the same age.

In studies involving inhaled corticosteroids, the average reduction in growth velocity was approximately one centimeter (about 1/3 of an inch) per year. It appears that the reduction is related to dose and how long the child takes the drug.

FDA's Pulmonary and Allergy Drugs and Metabolic and Endocrine Drugs advisory committees discussed this issue at a July 1998 meeting. They recommended that the agency develop class-wide labeling to inform health care providers so they would understand this potential side effect and monitor growth routinely in pediatric patients who are treated with inhaled corticosteroids, intranasal corticosteroids or both.

Long-term effects of this reduction in growth velocity on final adult height are unknown. Likewise, it also has not yet been determined whether patients' growth will "catch up" if treatment is discontinued. Drug manufacturers will continue to monitor these drugs to learn more about long-term effects.

Children are prescribed inhaled corticosteroids to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Approximately a dozen products will be relabeled to carry this new information.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first speaking to their health care providers about the benefits of these drugs compared to their risks.

For more information on this subject, see "Class Labeling for the Intranasal Corticosteroid Drug Products."

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