a SLACK Incorporated newspaper
December 1998
The new labeling language will alert health care providers that using these drugs in children may reduce their growth rate. It will recommend using the lowest effective dose of these drugs and routinely monitoring patients' growth.
Controlled clinical studies have shown that inhaled and intranasal corticosteroids may cause a reduction in growth velocity in children. Growth velocity provides a means of comparing the rate of growth among children of the same age.
In studies involving inhaled steroids, the average reduction in growth velocity was about 1 cm 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 meeting. They recommended that the agency develop class-wide labeling to inform health care providers so they would understand this potential side effect and routinely monitor growth in children who require inhaled and/or intranasal corticosteroids.
Long-term effects of this reduction in growth velocity on final adult height are unknown. It also has not 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 reactive airway disease. Intranasal corticosteroids are used to prevent and treat allergy-related nasal symptoms. Approximately one dozen products will be relabeled to carry this new information.
Advise patients not to stop using their inhaled or intranasal corticosteroids without first speaking to you about the benefits of these drugs compared to their risks.
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