Lisa Marie Kiesel, Astrid Bertsche, Wieland Kiess, Manuela Siekmeyer, Thilo Bertsche, Martina Patrizia Neininger
BACKGROUND: Children treated in a pediatric intensive care unit (PICU) often receive several drugs together, among them drugs defined as high-alert medications (HAMs). Those drugs carry a high risk of causing patient harm, for example, due to a higher potential for interactions. HAMs should therefore be administered with caution, especially in a PICU. OBJECTIVES: The objective of the current study was to identify drug-drug interactions involving HAMs that increase the risk of interaction-associated symptoms in pediatric intensive care...
July 4, 2024: Paediatric Drugs
Elizabeth A Hall, Tracy M Hagemann, Chasity M Shelton, Hilary M Jasmin, Alexis N Calvasina, Doralina L Anghelescu
Opioid therapy is the mainstay for managing pain in pediatric oncology. This narrative review describes the current literature regarding opioids for pediatric cancer pain. The review explores the multifaceted landscape of opioid utilization in this population, including the role of opioids in certain clinical circumstances, modalities of opioid delivery, unique opioids, outpatient and at-home pain management strategies, and other key concepts such as breakthrough pain. This review highlights the importance of individualized dosing and multimodal approaches to enhance efficacy and minimize adverse effects...
July 2, 2024: Paediatric Drugs
Annegret Dahlmann-Noor, Jill Bloom, Saw Keng Lee, Samiya Chowdhury, Kanwal Nischal, Dominique Bremond-Gignac
Many conditions managed by pediatric ophthalmologists are rare diseases, and even if pharmacological treatments are available, these have often not been evaluated in children. Off-label prescribing is a common practice in pediatric ophthalmology. In addition, there is often no commercial case for the production of a medicine that may only be used for a small number of patients worldwide. Compounded preparations prepared locally are therefore still in frequent use, although it is known that production may not meet stringent quality assurance standards...
June 27, 2024: Paediatric Drugs
Bo-Hao Tang, Qiu-Yue Li, Hui-Xin Liu, Yi Zheng, Yue-E Wu, John van den Anker, Guo-Xiang Hao, Wei Zhao
Bacterial infection is one of the major causes of neonatal morbidity and mortality worldwide. Finding rapid and reliable methods for early recognition and diagnosis of bacterial infections and early individualization of antibacterial drug administration are essential to eradicate these infections and prevent serious complications. However, this is often difficult to perform due to non-specific clinical presentations, low accuracy of current diagnostic methods, and limited knowledge of neonatal pharmacokinetics...
June 16, 2024: Paediatric Drugs
Connie Kang
Alirocumab (Praluent® ), a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor that has been co-developed by Regeneron Pharmaceuticals, Inc. and Sanofi (formerly sanofi-aventis), is approved globally for use in adults with established cardiovascular disease, primary hyperlipidemia [including heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH)]. In November 2023, based on clinical data in patients aged 8-17 years, alirocumab received its first pediatric approval in the EU as an adjunct to diet alone, or in combination with a statin and/or other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in pediatric patients aged ≥ 8 years with HeFH...
June 14, 2024: Paediatric Drugs
Lin Song, Ni Zhang, Ting-Ting Jiang, Yuntao Jia, Yao Liu
For more than two decades, regulatory agencies throughout the world released guidelines, rules and laws to stimulate and assist in paediatric drug development. In 2014, the National Health and Family Planning Commission (now known as the National Health Commission, NHC) and five other departments in China jointly issued 'Several Opinions on Safeguarding Medication for Children', after which several policies and regulations were issued to implement the priority review and approval of paediatric medicinal products and support the development of new drugs, including new dosage forms and strengths, for children...
June 5, 2024: Paediatric Drugs
Sohita Dhillon
Inotuzumab ozogamicin (BESPONSA™) is a CD22-targeted monoclonal antibody drug conjugate (ADC) developed by Pfizer for the treatment of CD22-postive B-cell precursor acute lymphoblastic leukaemia (ALL). Inotuzumab ozogamicin comprises a humanized IgG4 anti-CD22 monoclonal antibody covalently linked to the potent DNA-binding cytotoxic agent N-acetyl-gamma-calicheamicin dimethylhydrazide (CalichDMH) via a linker. Inotuzumab ozogamicin binds to CD22-expressing tumour cells, facilitating the delivery of conjugated CalichDMH, which after intracellular activation induces double strand DNA breaks, ultimately leading to cell cycle arrest and apoptotic cell death...
May 23, 2024: Paediatric Drugs
Shlomi Cohen, Helena Rolandsdotter, Kaija-Leena Kolho, Dan Turner, Christos Tzivinikos, Matteo Bramuzzo, Gemma Pujol-Muncunill, Luca Scarallo, Darja Urlep, Firas Rinawi, Maya Granot, Ben Kang, Ylva Longueville, Marta Velasco Rodríguez-Belvís, Yael Weintraub, Víctor Manuel Navas-López, Anat Yerushalmy-Feler
BACKGROUND AND OBJECTIVES: Current data on ustekinumab therapy in children with ulcerative colitis (UC) or unclassified inflammatory bowel disease (IBDU) are limited. We aimed to evaluate the effectiveness and safety of ustekinumab in pediatric UC and IBDU. METHODS: This multicenter retrospective study included 16 centers affiliated with the IBD Interest and Porto groups of ESPGHAN. Children with UC or IBDU treated with ustekinumab were enrolled. Demographic, clinical, laboratory, endoscopic, and imaging data as well as adverse events were recorded...
May 23, 2024: Paediatric Drugs
Chance S Friesen, Valentina Shakhnovich, Paul Toren, Brandon Retke, Jennifer Schurman, Jennifer Colombo, Amanda Deacy, Craig A Friesen, Susan Abdel-Rahman
BACKGROUND AND OBJECTIVE: Mast cells have been implicated in abdominal pain-associated disorders of gut-brain interaction, such as functional dyspepsia. As such, ketotifen, a second-generation antihistamine and mast cell stabilizer, could represent a viable treatment option in these conditions. The primary aim of the current pilot study was to assess clinical response to ketotifen and assess pharmacokinetics in youth with functional dyspepsia. METHODS: We conducted a pilot randomized, double-blind, placebo-controlled, cross-over trial of ketotifen in 11 youth with functional dyspepsia and duodenal mucosal eosinophilia with 4 weeks of active treatment at a dose of 1 mg twice daily...
May 21, 2024: Paediatric Drugs
Paulo Sérgio Lucas da Silva, Emerson Yukio Kubo, Rafael da Motta Ramos Siqueira, Marcelo Cunio Machado Fonseca
BACKGROUND: Ketamine has been considered as an adjunct for children who do not reach their predefined target sedation depth. However, there is limited evidence regarding the use of ketamine as a prolonged infusion (i.e., >24 hours) in the pediatric intensive care unit (PICU). OBJECTIVE: We sought to evaluate the safety and effectiveness of continuous ketamine infusion for >24 hours in mechanically ventilated children. METHODS: We conducted a prospective cohort study in a tertiary PICU from January 2020 to December 2022...
May 19, 2024: Paediatric Drugs
Kevin Meesters, Violeta Balbas-Martinez, Karel Allegaert, Kevin J Downes, Robin Michelet
The widespread use of drugs for unapproved purposes remains common in children, primarily attributable to practical, ethical, and financial constraints associated with pediatric drug research. Pharmacometrics, the scientific discipline that involves the application of mathematical models to understand and quantify drug effects, holds promise in advancing pediatric pharmacotherapy by expediting drug development, extending applications, and personalizing dosing. In this review, we delineate the principles of pharmacometrics, and explore its clinical applications and prospects...
May 16, 2024: Paediatric Drugs
Aslı İnci, Fatih Süheyl Ezgü, Leyla Tümer
Inborn errors of metabolism (IEMs) are a group of genetic diseases that occur due to the either deficiency of an enzyme involved in a metabolic/biochemical pathway or other disturbances in the metabolic pathway including transport protein or activator protein deficiencies, cofactor deficiencies, organelle biogenesis, maturation or trafficking problems. These disorders are collectively significant due to their substantial impact on both the well-being and survival of affected individuals. In the quest for effective treatments, enzyme replacement therapy (ERT) has emerged as a viable strategy for patients with many of the lysosomal storage disorders (LSD) and enzyme substitution therapy in the rare form of the other inborn errors of metabolism including phenylketonuria and hypophosphatasia...
April 25, 2024: Paediatric Drugs
Fernando Ferrero, Chien-Yu Lin, Johannes Liese, Kleber Luz, Tatyana Stoeva, Agnes Nemeth, Manuel Gijón, Cristina Calvo, Silvina Natalini, Teck-Hock Toh, Sofie Deleu, Bohang Chen, Sarah Rusch, Beatriz López Sánchez, Illse Leipoldt, Leen Vijgen, Dymphy Huntjens, Tristan Baguet, Kristi Bertzos, Mohamed Gamil, Marita Stevens
BACKGROUND: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in children aged ≤ 5 years and adults aged ≥ 60 years worldwide. Despite this, RSV-specific therapeutic options are limited. Rilematovir is an investigational, orally administered inhibitor of RSV fusion protein-mediated viral entry. OBJECTIVE: To establish the antiviral activity, clinical outcomes, safety, and tolerability of rilematovir (low or high dose) in children aged ≥ 28 days and ≤ 3 years with RSV disease...
April 22, 2024: Paediatric Drugs
Sana Younus, Lauren Havel, Jordan T Stiede, Catherine E Rast, Kirti Saxena, Wayne K Goodman, Eric A Storch
Pediatric obsessive-compulsive disorder (OCD) is a chronic, potentially debilitating psychiatric condition. Although effective treatments exist, at least 10% of youth do not achieve remission despite receiving first-line treatments. This article reviews the extant, albeit limited, evidence supporting treatment approaches for youth with treatment-resistant OCD. A literature search for articles addressing pediatric treatment-resistant OCD was conducted through April 11, 2024. These results were augmented by searching for treatment-resistant OCD in adults; treatment strategies discovered for the adult population were then searched in the context of children and adolescents...
July 2024: Paediatric Drugs
Dilara Unal, Veysel Cam, Hulya Ercan Emreol, Seza Özen
Neuropsychiatric systemic lupus erythematosus (NPSLE) is a potentially serious and life-threatening complication of SLE. The presentation and severity of neuropsychiatric involvement in SLE may show considerable variability. The disease can affect the neural tissue directly or may be associated with vascular involvement, mainly associated with anti-phospholipid (aPL) antibodies. A direct causal link with SLE may sometimes be challenging since there are many confounding factors and the symptoms may be non-specific...
July 2024: Paediatric Drugs
Katherine B Snyder, Catherine J Hunter, Christie L Buonpane
Although appendicitis has been described for more than 300 years, its optimal management remains a topic of active investigation. Acute appendicitis is the most common cause of peritonitis in children, and rates of perforated appendicitis are much higher in children than in adults. Increased risk for perforated appendicitis in children is related to a delay in diagnosis due to age, size, access to care, and more. Surgical options include immediate appendectomy versus nonoperative management with intravenous antibiotics ± a drainage procedure, with a subsequent interval appendectomy...
May 2024: Paediatric Drugs
Sebastiano A G Lava, Craig Laurence, Alessandro Di Deo, Nicole Sekarski, Michael Burch, Oscar Della Pasqua
INTRODUCTION: In adults, sodium-glucose cotransporter type 2 inhibitors have revolutionised the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease. OBJECTIVE: We aimed to review information on compassionate use, clinical pharmacology, efficacy, and safety of dapagliflozin and empagliflozin in children. METHODS: We conducted a systematic review of published clinical trials, case reports, and observational studies in Medline, Excerpta Medica, and Web of Science databases from inception to September 2023...
May 2024: Paediatric Drugs
Amara Nassar-Sheikh Rashid, Femke Hooijberg, Sandy C Bergkamp, Mariken P Gruppen, Taco W Kuijpers, Mike Nurmohamed, Theo Rispens, Gertjan Wolbink, J Merlijn van den Berg, Dieneke Schonenberg-Meinema, Ron A A Mathôt
BACKGROUND AND OBJECTIVE: Juvenile idiopathic arthritis (JIA) is a chronic autoimmune disorder that primarily affects the joints in children. Notably, it is known to co-occur with uveitis. Adalimumab, a monoclonal anti-TNF antibody, is effective in treating both conditions. A deeper understanding of the pharmacokinetics (PK) of adalimumab in JIA is crucial to advance in more personalized treatment approaches. The objective of this study is to evaluate the population PK profile of adalimumab in JIA and to explain causes for its variability...
April 17, 2024: Paediatric Drugs
Iris K Minichmayr, Ursula Knaack, Johannes Gojo, Daniel Senfter, Christine Haberler, Amedeo A Azizi, Lisa Mayr, Markus Zeitlinger, Andreas Peyrl
BACKGROUND: To date, evidence has been lacking regarding bevacizumab pharmacokinetics in the cerebrospinal fluid (CSF). OBJECTIVE: This study assessed the penetration of bevacizumab, as part of a metronomic antiangiogenic treatment regimen, into the CSF of children, adolescents, and young adults with recurrent brain tumors. PATIENTS AND METHODS: Serum and CSF concentrations, malignant cells, and vascular endothelial growth factor A (VEGF-A) were analyzed in 12 patients (5-27 years) following 10 mg/kg bevacizumab intravenous biweekly administration (EudraCT number 2009-013024-23)...
April 8, 2024: Paediatric Drugs
Annette Gawron Roberts, Noelle Younge, Rachel Gottron Greenberg
Necrotizing enterocolitis (NEC) is a life-threatening disease predominantly affecting premature and very low birth weight infants resulting in inflammation and necrosis of the small bowel and colon and potentially leading to sepsis, peritonitis, perforation, and death. Numerous research efforts have been made to better understand, treat, and prevent NEC. This review explores a variety of factors involved in the pathogenesis of NEC (prematurity, low birth weight, lack of human breast milk exposure, alterations to the microbiota, maternal and environmental factors, and intestinal ischemia) and reports treatment modalities surrounding NEC, including pain medications and common antibiotic combinations, the rationale for these combinations, and recent antibiotic stewardship approaches surrounding NEC treatment...
April 2, 2024: Paediatric Drugs
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