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11/10/1998

FDA Mandates New Pediatric Labeling for Inhaled, Intranasal Corticosteroids

Cheryl A. Thompson

FDA informed companies of new pediatric information that will be required on labels of inhaled and intranasal corticosteroids. The new language will alert health care providers of the potential of these drugs to impede the growth of children. It will also recommend using the lowest effective dose and that the growth rate be monitored routinely.

The long-term effects on final adult height are unknown and it also has not been determined if growth rate will “catch up” once treatment is discontinued. 

Approximately a dozen products will be relabeled to carry this new information. Drug manufacturers will continue to monitor these drugs to learn more about long-term effects. For more on the talk paper, click here. For more information about class labeling, click here