{"title":"Systematic Review of Adverse Events of IL-1 and IL-6 Inhibitor Use in Pediatrics.","authors":"Amandi Perera, Nikita Chugh, Facundo Garcia-Bournissen","doi":"10.5863/1551-6776-30.2.152","DOIUrl":"10.5863/1551-6776-30.2.152","url":null,"abstract":"<p><strong>Objective: </strong>Two, relatively new and potent, classes of biologicals are interleukin-6 (IL-6) and interleukin-1 (IL-1) inhibitors. As the use of these biologicals in children is more recent, the nature and incidence of adverse effects in the pediatric population are less well known. We systematically reviewed the available literature to elucidate the risks of IL-1 and IL-6 inhibitor use in the pediatric population.</p><p><strong>Methods: </strong>A systematic literature search was conducted including English-language clinical studies of children who received IL-1 or IL-6 inhibitors for therapeutic purposes. Abstracts and full-text screening of manuscripts were carried out by 2 independent reviewers, based on predefined eligibility criteria. Any conflicts between the 2 reviewers were resolved by a third reviewer. Data extracted included characteristics such as intervention (drug, dose, method of administration, frequency), adverse events, and frequency of adverse events.</p><p><strong>Results: </strong>A total of 2707 studies were screened and 38 studies were selected for inclusion. Of these 38 studies, 9 involved canakinumab, 12 involved anakinra, 2 involved rilonacept, 15 involved tocilizumab, and 1 involved an unspecified recombinant IL-6 antagonist. The most common adverse events included infection, local injection site reactions, headache, fever, arthralgia, and rash. There were 557 serious adverse events reported in 2208 patients (rate = 25%).</p><p><strong>Conclusions: </strong>Risks of biological use should be considered alongside the immunosuppressive benefits when prescribing IL-1 and IL-6 inhibitors in the pediatric population. Few data were available on long-term follow-up of these patients.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"152-169"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Use of Endotracheal Cocaine Solution for Pulmonary Hemorrhage in the Neonate.","authors":"Jacob Kelner, Christine Bohnsack, Naveed Hussain","doi":"10.5863/1551-6776-30.2.268","DOIUrl":"10.5863/1551-6776-30.2.268","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"268-270"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288561/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Diphenhydramine: A Review of Its Clinical Applications and Potential Adverse Effect Profile.","authors":"Wajahat Nazir Khan, Joseph D Tobias","doi":"10.5863/1551-6776-30.2.182","DOIUrl":"10.5863/1551-6776-30.2.182","url":null,"abstract":"<p><p>Diphenhydramine (Benadryl) is a first-generation antihistamine that is primarily used to treat allergic reactions including anaphylaxis, urticaria, and allergic rhinitis. Despite its availability as an over-the-counter medication, adverse physiologic effects and toxicity may occur with its use especially when administered rapidly via the intravenous route or when administered in large or excessive doses. The development and history of diphenhydramine is presented, its physiologic effects and clinical uses outlined, previous reports of clinically significant and potentially life-threatening adverse effects reviewed, and options to limit these effects discussed.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"182-190"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288571/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"WHO and Its Enduring Commitment to Global Pediatrics.","authors":"Peter J Hotez","doi":"10.5863/1551-6776-30.2.282","DOIUrl":"10.5863/1551-6776-30.2.282","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"282-285"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shayne Hughes, Max Blumenthal, Alexis Johnson, Jamie Limjoco, Sin Yin Lim
{"title":"Pharmacokinetics and Pharmacodynamics of Levetiracetam in Neonatal Seizures: What We Still Need to Know.","authors":"Shayne Hughes, Max Blumenthal, Alexis Johnson, Jamie Limjoco, Sin Yin Lim","doi":"10.5863/1551-6776-30.2.170","DOIUrl":"10.5863/1551-6776-30.2.170","url":null,"abstract":"<p><p>Neonatal seizures affect 1 to 4 neonates per 1000 live births and are associated with increased mortality and neurological impairment. Currently, phenobarbital is recommended as the first-line treatment; however, its limited efficacy and serious safety concerns are significant drawbacks. Levetiracetam, a newer generation anti-seizure medication with minimal reported adverse effects, is commonly used off label for the treatment of neonatal seizures. Earlier studies showed limited efficacy of levetiracetam in neonatal seizures; however, these studies were limited by the lack of pharmacokinetic-pharmacodynamic data for larger doses (>60 mg/kg). The pharmacokinetics of levetiracetam differ in neonates compared to children and adults. In neonates, the volume of distribution of levetiracetam can exceed that in children and adults. By 7 days of postnatal age, the clearance approaches that of children, which also exceeds the clearance reported in adults. There are limited pharmacodynamic studies of levetiracetam in neonatal seizures. Because the pathophysiology of seizures and the treatment goals in neonates differ from those in children and adults, critical information on the pharmacodynamics of levetiracetam at larger doses is still needed to confirm its efficacy or lack thereof.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"170-181"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Layne M Smith, Francis L Casey Iii, Dhaval Chauhan, Christopher E Mascio, Margaret Mathewson, Jai Udassi
{"title":"Evaluation of a Bivalirudin Dosing and Monitoring Protocol in Pediatric Extracorporeal Membrane Oxygenation.","authors":"Layne M Smith, Francis L Casey Iii, Dhaval Chauhan, Christopher E Mascio, Margaret Mathewson, Jai Udassi","doi":"10.5863/1551-6776-30.2.218","DOIUrl":"10.5863/1551-6776-30.2.218","url":null,"abstract":"<p><strong>Objective: </strong>Bivalirudin is a direct thrombin inhibitor used off-label for systemic anticoagulation in extracorporeal membrane oxygenation (ECMO). There are limited data available in pediatric patients, specifically regarding optimal dosing in this heterogeneous population of patients. This study aimed to characterize bivalirudin use in pediatric patients on ECMO at a single center.</p><p><strong>Methods: </strong>A retrospective chart review was conducted for consecutive patients undergoing ECMO at a quaternary center between January 2021 and June 2023 who received bivalirudin as the primary anticoagulation agent. The primary outcome was the dose of bivalirudin required to achieve activated partial thromboplastin time (aPTT) in the goal range. Additionally, time in therapeutic range, time to initial aPTT goal, dose adjustments required in patients receiving renal replacement therapy, amount of blood and blood products received, incidence of major bleeding, and complete ECMO circuit changes were evaluated.</p><p><strong>Results: </strong>Fourteen patients, including 6 neonates, 5 children, and 3 adolescents, were included in the study. Eleven patients were initially placed on venoarterial ECMO, and 3 were initially placed on venovenous ECMO. The median ECMO duration was 6 days. The median dose of bivalirudin required to achieve the initial goal aPTT level varied between neonates, children, and adolescents (0.1 mg/kg/hr, 0.2 mg/kg/hr, 0.05 mg/kg/hr, respectively).</p><p><strong>Conclusions: </strong>Multiple patient factors including age, indication for ECMO, renal function, and hepatic function must be taken into consideration when determining a starting dose of bivalirudin for these pediatric patients.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"218-225"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jieun David, Cristina Foschi, Michelle M Greene, Kristen Click, Beau Hunsinger, Kousiki Patra
{"title":"Neurodevelopmental Outcome at 20 Months Corrected Age in Extremely Preterm Infants After Exposure to Dexamethasone and Hydrocortisone in the NICU.","authors":"Jieun David, Cristina Foschi, Michelle M Greene, Kristen Click, Beau Hunsinger, Kousiki Patra","doi":"10.5863/1551-6776-30.1.84","DOIUrl":"10.5863/1551-6776-30.1.84","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the association between hydrocortisone (HC) and dexamethasone (DEX) exposure in the NICU on neurodevelopmental (ND) outcome in extremely preterm (EPT; GA <28 weeks) infants.</p><p><strong>Methods: </strong>This is a single-center retrospective cohort chart review of EPT infants born between 2011 to 2016 compared in terms of ND outcome at 20 months corrected age (CA). Steroid exposures, sociodemographic factors and neonatal comorbidities were collected. Outcome measures included neurologic exam and -Bayley-3 testing. Multiple regression analyses adjusted for effects of risk factors on outcome.</p><p><strong>Results: </strong>Of the 221/264 survivors, 138 had no steroid exposure, 47 received HC only and 36 received DEX ± HC. Steroid-exposed groups were of lower birth weight and gestational age and had higher rates of neonatal comorbidities. Total duration and cumulative dosage of HC was not significantly different between steroid-exposed groups. Infants exposed to DEX ± HC had significantly lower Bayley-3 indices as compared with the no-steroid and HC only group. In linear regression analyses, DEX ± HC was associated with a 10-point reduction in cognitive (p < 0.01), language (p < 0.05), and motor (p < 0.01) indices.</p><p><strong>Conclusions: </strong>In EPT infants, prolonged, repeated steroid exposure with DEX ± HC was associated with adverse cognitive, language and motor outcomes at 20 months CA. Further research may expose the -cumulative effect of steroids in this vulnerable population.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 1","pages":"84-92"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809538/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Madison Roberts, Theresa Potter, Kristi Wilmot, India Sisler, Cady Noda
{"title":"Evaluation of Olanzapine for the Prevention of Refractory Chemotherapy-Induced Vomiting in Pediatric Oncology Patients.","authors":"Madison Roberts, Theresa Potter, Kristi Wilmot, India Sisler, Cady Noda","doi":"10.5863/1551-6776-30.1.106","DOIUrl":"10.5863/1551-6776-30.1.106","url":null,"abstract":"<p><strong>Objective: </strong>The use of olanzapine for control of chemotherapy-induced vomiting (CIV) has increased; however, data on safety and efficacy in pediatric patients are limited. The primary objective of this study is to assess olanzapine for the prevention of refractory CIV in pediatric oncology patients.</p><p><strong>Methods: </strong>This study is a retrospective, cross-control study of patients admitted to a pediatric hematology oncology service. Complete control of CIV was defined as no documented emesis and no administration of rescue antiemetics. For inclusion, patients had to have 1 encounter without and 1 encounter with olanzapine. Exclusion criteria included olanzapine use outside of CINV indication or olanzapine administration occurring after the start of chemotherapy.</p><p><strong>Results: </strong>A total of 26 patients were included, with a median age of 14 years (IQR, 11.74-15.26) and median baseline weight of 56.2 kg (53.35-68.83). The median olanzapine dose administered was 0.089 mg/kg/dose. Olanzapine administration resulted in a higher number of patients achieving complete control of CIV (30.7% vs 11.5%; p = 0.001), reduction in doses of rescue antiemetic agents administered (1 vs 3 doses; p = 0.0117), but increase in documented somnolence by nurse assessment in patients receiving olanzapine (15.4% vs 7.7%; p < 0.001).</p><p><strong>Conclusion: </strong>The addition of olanzapine appears effective at achieving complete control of CIV when used for the prevention of refractory CIV.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 1","pages":"106-111"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809536/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143399947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kimberly A Pesaturo, Timothy McMath, Evan R Horton
{"title":"The Pharmacist's Role in the Care of Pediatric Emergency Department Patients.","authors":"Kimberly A Pesaturo, Timothy McMath, Evan R Horton","doi":"10.5863/1551-6776-30.1.138","DOIUrl":"10.5863/1551-6776-30.1.138","url":null,"abstract":"<p><p>The Pediatric Pharmacy Association (PPA) strongly urges health care institutions to establish and support the pharmacist's role in pediatric emergency department (ED) settings. Adult patient-centric guidelines have firmly established the general role of the pharmacist and pharmacy services in emergency medicine; however, pediatric pharmacy presence is often considered in case-based scenarios, such as pediatric cardiopulmonary resuscitation events. PPA recommends supporting the pharmacist's role in all pediatric ED settings and scenarios including, but not limited to, participation in direct patient care activities, education, safety, improvement initiatives, and transitions of care. Further, PPA advocates for the provision of appropriate training, credentialing, and ongoing mentorship and competency in these areas.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 1","pages":"138-142"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809526/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rou-Yee Chenhsu, Brent A Hall, Heidi Tran, Monica A Donnelley, Ritu Cheema, Natasha A Nakra
{"title":"Vancomycin Area Under the Curve to Minimum Inhibitory Concentration Ratio for Treatment Effectiveness in Pediatric and Neonatal Staphylococcal Infections: A Systematic Review.","authors":"Rou-Yee Chenhsu, Brent A Hall, Heidi Tran, Monica A Donnelley, Ritu Cheema, Natasha A Nakra","doi":"10.5863/1551-6776-30.1.52","DOIUrl":"10.5863/1551-6776-30.1.52","url":null,"abstract":"<p><strong>Objective: </strong>To review pediatric data on vancomycin exposure threshold against methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) and coagulase-negative staphylococci (MR-CoNS).</p><p><strong>Methods: </strong>A systematic review was conducted through July 2023. Publications in English that explored vancomycin effectiveness threshold against MRSA, CoNS, or <i>S aureus</i> in pediatrics were eligible. Effectiveness examined included clinical improvement, microbiologic sterilization, recurrence, and mortality, as defined by each individual study.</p><p><strong>Results: </strong>Twelve studies were eligible. One on MRSA bacteremia (MRSA-B) identified an area under the curve to minimum inhibitory concentration ratio (AUC:MIC) of 300 mg × hr/L associated with rapid bacteremia clearance. Two on CoNS bacteremia (percentage of MR-CoNS unreported) demonstrated an AUC of 300 mg x hr/L regardless of MIC and an AUC:MIC of 280 mg × hr/L for bacteriologic cure, respectively; and one on <i>S aureus</i> bacteremia (25.5% MRSA) found an AUC:MIC of 400 mg × hr/L for clinical improvement.</p><p><strong>Conclusions: </strong>There is overall limited pediatric data, and the observed AUC:MIC thresholds should be interpreted as hypothesis generating only. Further, the effectiveness outcome could be refined in future research by using time to bacteremia clearance only, as odds of complications increase with each additional day of MRSA-B, whereas the definition of recurrence is not standardized, and mortality is low. Additionally, extrapolating AUC:MIC for MRSA to CoNS is beyond the stated usage of current guidelines. To achieve an AUC:MIC ratio against CoNS with a MIC of >1 mg/L would require higher AUC with potential nephrotoxicity. More data on AUC (regardless of MIC) for MR-CoNS bacteremia are needed.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 1","pages":"52-64"},"PeriodicalIF":0.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809528/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}