Pediatric products with overlapping age directions not inherent problem -- NDAC's Brass.
This article was originally published in The Tan Sheet
Executive Summary
PEDIATRIC OTCs OVERLAPPING AGE DIRECTIONS NOT INHERENT PROBLEM in the opinion of FDA Nonprescription Drugs Advisory Committee member Eric Brass, MD/PhD, Harbor UCLA Medical Center. Brass' comment came during NDAC's Sept. 18 meeting in Gaithersburg, Md. on whether safety problems or dosing errors result from an age overlap in the two- to three-year-old age group in labeling directions for the use of two different strengths of pediatric analgesic/antipyretic drugs: regular strength liquid and more concentrated drops. The directions for use for these products are not "intrinsically" a problem, Brass said, but there may be "problems relating to label comprehension," he added.