FDA said more than half the drugs approved each year likely to be used by children have insufficient information about safe dosage. In a related action, FDA is requiring manufacturers of corticosteroid drugs used to treat asthma or allergy to state on the label that the drug may slow a child's growth. Studies have shown that a child taking the drug every day for one year grew an average of 1/3" less per year compared to other children of the same age. In early November, the agency sent letters to pharmaceutical manufacturers asking them to submit new labeling for approval within 60 days. The rule applies to about a dozen medications in what has become a rapidly growing class of drugs.
Drug labeling for kids
FDA has issued new labeling rules designed to clarify drug dosage for children. Labels for drugs frequently prescribed in pediatric cases must contain appropriate dosages for children.
Dec 31st, 1998