Understanding Pediatric Drug Lag Time: Review of Selected Drug Package Inserts
Aviva Beleck1, Sharon Nachman1
1Department of Pediatrics, Renaissance School of Medicine, Stony Brook University, Stony Brook, New York, USA.
Journal of the Pediatric Infectious Diseases Society
|December 8, 2020
Summary
Pediatric drug approvals are delayed by 8 years, partly due to concerns about impacting adult drug licensure. However, this review found no evidence that pediatric trials negatively affect adult drug safety or approval. Pediatric drug development can proceed in parallel with adult studies.
Area of Science:
- Pharmaceutical Science
- Pediatric Clinical Trials
- Drug Regulatory Affairs
Background:
- Pharmaceutical drug approval for pediatric use faces significant delays compared to adults.
- A key concern cited for these delays is the potential for simultaneous pediatric and adult trials to negatively impact adult drug licensure.
Purpose of the Study:
- To investigate whether pediatric clinical trials introduce new safety concerns that could jeopardize adult drug licensure.
- To evaluate the validity of concerns regarding parallel pediatric and adult drug trials affecting adult drug approval.
Main Methods:
- Review of drug package inserts from the U.S. Food and Drug Administration (FDA) database.
- Analysis of 5 selected pharmaceutical agents before and after their FDA approval for pediatric use.
Main Results:
- No new contraindications, warnings, or adverse events were identified in pediatric trials that posed a risk to adult licensure.
- Observed changes in package inserts were primarily attributed to ongoing adult clinical trials and post-marketing surveillance in adults.
Conclusions:
- The concern that pediatric trials may negatively impact adult drug licensure appears unsubstantiated.
- Simultaneous pediatric and adult drug trials are likely justifiable and may expedite access to medications for children.
Related Concept Videos
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
111
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
111
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
109
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
109
01:17Pharmacokinetics in Pediatric Patients: Drug Distribution
137
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
137
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
91
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
91
01:21Factors Affecting Drug Response: Overview
2.7K
When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
2.7K
01:29Drug Dosing: Infants and Children
111
Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
111