Advances in Pediatric Pharmacology, Therapeutics, and Toxicology

Abstract

In the United States, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act continue to promote clinical trials in pediatric populations across all age ranges. In 2014 and 2015, over 70 changes were made to drug labels with updates on information regarding pediatric populations. Additionally, multiple new therapies have received first-approvals for the treatment of pediatric indications ranging form rare genetic metabolic diseases to oncology. In the European Union, there have been more than 30 new authorizations for medicines used in children and 130 approved pediatric investigation plans. Despite the progress that has been made over the last two years, much work remains to further the development of safe and effective therapies for pediatric patients.

Hypertensive Crisis in a Pediatric Patient Experiencing Clonidine Withdrawal

“…Though various reports exist for clonidine withdrawal in adults [ 2 , 3 , 7 , 8 , 18 , 19 ], little has been reported on this syndrome in children. Given the rise in use of clonidine in pediatrics [ 1 , 9 – 11 ], it is important to raise awareness of the dramatic presentation that can occur after abrupt cessation or rapid tapering of clonidine.…”

“…[ 6 – 8 ]. Recently, clonidine has been increasingly used in pediatric patients for a variety of indications, including attention deficit hyperactivity disorder (ADHD), drug withdrawal, chronic pain, behavioral disorders, and sleep disturbance [ 9 – 11 ], with a significant rise in pediatric clonidine utilization between 2000 and 2014 [ 1 , 9 , 12 ]. Given the frequent use of clonidine and the array of clinical situations in which it may be used, recognizing the presentation and treatment of clonidine withdrawal is essential [ 1 , 12 ].…”

<p>Bioavailability and swallowability of an age-appropriate, delayed-release mesalamine formulation in healthy volunteers</p>

“…However, the data from this study are limited by the fact that bioequivalence was examined only in adults. PK properties for delayed-release mesalamine have not been explored in children beyond mean plasma concentrations in clinical trials with limited numbers of participants 8,9,16. This may be due to challenges in conducting pediatric PK studies for both logistical (eg, recruitment) and ethical reasons.…”

Uso de medicamentos em crianças menores de um ano

“…(11) Nos Estados Unidos, existe a Lei Melhores Produtos Farmacêuticos para Crianças e a Lei de Equidade em Pesquisa Pediátrica, que promove ensaios clínicos em populações pediátricas em todas as faixas etárias, realizando a atualização de medicamentos referente à essa população, embora, apesar do progresso, muitos estudos ainda devem ser realizados para promover o desenvolvimento de terapias seguras e eficazes para pacientes pediátricos. (12) Muitos guidelines -diretrizes -para monitoramento e gerenciamento de pacientes pediátricos antes, durante e após a procedimentos terapêuticos, são realizados na tentativa de minimizar os danos, e reduzir os efeitos adversos que os medicamentos podem desencadear nesta população, no entanto, estes guidelines costumam ser direcionados para fármacos utilizados preferencialmente no ambiente hospitalar, ou de uso controlado por prescrição médica, não abrangendo os remédios de venda livre. (13)(14)(15)(16) A dose dos medicamentos para população pediátrica é calculada de acordo com o peso ou superfície corporal, idade e quadro clínico.…”