Labeling of Drug and Biologic Products for Pediatric Use
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Drug Information Journal. Vol. 32, pp. 299-303, 1998
Printed in the USA. All rights reserved.
LABELING OF DRUG AND BIOLOGIC PRODUCTS FOR PEDIATRIC USE EMILYSHACTER,PHD Senior Staff Fellow, Division of Hematologic Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland
PATRICIA L. DESANTIS Drug Review Program Director, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland
Drugs and biological therapeutics are commonly prescribed to pediatric patients in the absence of adequate dosage and administration information in the product label. This paper describes issues surrounding labeling of drugs and biologics for pediatric use. It includes a discussion of why drugs and biologics should be labeled with pediatric use information, an update on the status of regulatory guidance for pediatric labeling, and a summary of recent steps taken by the Food and Drug Administration (FDA) to increase the number of therapeutic products that contain appropriate labeling for pediatric use. Key Words: Drugs; Biologics; Labeling; Pediatrics; Regulations
MOST PRESCRIPTION DRUGS and bio- tain either a disclaimer or lack of dose inforlogical therapeutics contain little or no dos- mation for pediatric use (1). Examination of age information for administration to pediat- subsequent time periods shows that this value ric patients. This information is provided to has not changed significantly over the years the health care practitioner in the product (Figure 1). In the 1991 PDR, 81% of drugs label. Some classes of drugs and biologics and biologics had little or no information such as vaccines and antibiotics generally on pediatric use (1). Analysis of the labeling have adequate labeling information for pedi- for new molecular entities (NMEs) approved atric use while other drug classes are particu- between 1991 and 1996 revealed a similar larly deficient; for example, steroids, drugs to statistic. These values are somewhat skewed treat gastrointestinal problems, prescription by the fact that not all drugs and biologics pain medications, antihypertensives, and an- have usefulness in pediatric patients. If tidepressants. Despite efforts to increase the NMEs with potential usefulness in pediatric rate of labeling of drugs for pediatric use, patients are analyzed, approximately 40% little has changed over the past two decades. have pediatric labeling. The remainder are A survey of the 1973 Physicians Desk Refer- prescribed in the absence of specific direcence (PDR) showed that 78% of drugs con- tions for pediatric use. Why is pediatric labeling of drugs and biologics needed? Defined as individuals unResented at the DIA 33rd Annual Meeting “Optimizing der the age of 16, the pediatric population is Pharmaceutical Development: The Global Experience,” further broken down into the subgroups of June 22-26, 1997, Montreal, Canada. Reprint address: Dr. Emily Shacter, FDNCBER, neonates (birth to 1 month of age), infants HFM-538, Bldg. 29A, Rm. 2A-11, 29 Lincoln Drive, (
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