{"title":"Pharmacologic Management of Patent Ductus Arteriosus in the Neonatal Intensive Care Unit: A Retrospective Study.","authors":"Gurleen Gill, Brandi Newby","doi":"10.5863/1551-6776-30.2.250","DOIUrl":"10.5863/1551-6776-30.2.250","url":null,"abstract":"<p><strong>Objective: </strong>Patent ductus arteriosus (PDA) is common in premature neonates. The use and selection of pharmacologic therapy are controversial because of unclear long-term benefits and the potential of adverse effects. The objective of this review was to explore the safety and efficacy for indomethacin, ibuprofen, and acetaminophen for PDA management.</p><p><strong>Methods: </strong>A chart review was conducted for neonates who received pharmacologic treatment for PDA at our institution between July 1, 2016, and May 30, 2023. Data collected included treatment success or failure; adverse reactions to the medications, including renal dysfunction, gastrointestinal perforation or bleeding, hepatotoxicity, and/or death; and complications, including bronchopulmonary dysplasia, pulmonary hypertension, surgical closure, and death before discharge.</p><p><strong>Results: </strong>A total of 91 neonates met the inclusion criteria. The efficacy rates for the first treatment course were 25 of 31 (80.6%) for indomethacin, 4 of 16 (25%) for ibuprofen, and 27 of 44 (61.4%) for acetaminophen. Complications occurred in 12 of 31 (38.7%) for indomethacin, 9 of 16 (56.3%) for ibuprofen, and 0 of 44 (0%) for acetaminophen.</p><p><strong>Conclusion: </strong>Indomethacin and acetaminophen had good efficacy, though indomethacin had a high incidence of complications. Ibuprofen had lower efficacy than expected (25%) and concerning safety outcomes, which requires further investigation to see if ethnicity plays a role.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"250-257"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733710","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":"Correspondence on \"Gabapentin for Delirium in Infants in the Neonatal Intensive Care Unit\".","authors":"","doi":"10.5863/1551-6776-30.2.298","DOIUrl":"10.5863/1551-6776-30.2.298","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"298-301"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733682","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":"Kratom's Use and Impact on Pediatric Populations.","authors":"C Michael White","doi":"10.5863/1551-6776-30.2.289","DOIUrl":"10.5863/1551-6776-30.2.289","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"289-293"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733687","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":"Pediatric Overdose Deaths Increase as the Fourth Wave of the Opioid Epidemic Creates a Perfect Storm.","authors":"Jeremy R Canfield, Jon E Sprague","doi":"10.5863/1551-6776-30.2.294","DOIUrl":"10.5863/1551-6776-30.2.294","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"294-297"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288577/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733708","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}
Awol Mekonnen Ali, Haileyesus Adam, Daniel Hailu, Johanne Groothuismink, Marieke J H Coenen, Rawleigh Howe, Teferra Abula
{"title":"Relationship Between Thiopurine S-Methyltransferase Genotype and Phenotype in Pediatric Acute Lymphoblastic Leukemia in Addis Ababa, Ethiopia.","authors":"Awol Mekonnen Ali, Haileyesus Adam, Daniel Hailu, Johanne Groothuismink, Marieke J H Coenen, Rawleigh Howe, Teferra Abula","doi":"10.5863/1551-6776-30.2.212","DOIUrl":"10.5863/1551-6776-30.2.212","url":null,"abstract":"<p><strong>Objective: </strong>Thiopurine S-methyltransferase (TPMT) is a cytosolic transmethylase enzyme that catalyzes the S-methylation of thiopurine drugs, the mainstay of acute lymphoblastic leukemia treatment. TPMT enzyme activity shows interindividual variability, which can partly be explained by genetic variants in the <i>TPMT</i> gene. In this study, we aimed to investigate the concordance between genotype and phenotype of <i>TPMT</i> gene in a cohort of patients with acute lymphoblastic leukemia from Ethiopia.</p><p><strong>Methods: </strong>In the present study, 73 on treatment and 32 treatment completed patients were included. TPMT activity was measured in whole blood of the participant by HPLC. The enzyme activity was expressed both in nmol6MTG/gHb/h and mU/L. The 3 most common variants in the <i>TPMT</i> gene (238G>C, 460G>A, and 719A>G) were genotyped.</p><p><strong>Results: </strong>Only 2 patients carried the *3C variant (719A>C) (both heterozygous), no other variants were detected. In the treatment group, TPMT activity (nmol6MTG/gHb/h) was significantly higher than the treatment completed group (32 vs 25.55, p = 0.018). In the treatment group TPMT activity (nmol6MTG/gHb/h) was significantly higher in individuals with Hb < 12 g/dL compared with individuals with Hb ≥ 12 g/dL (34.05 vs 27, p = 0.037).</p><p><strong>Conclusions: </strong>This study showed that the commonly genotyped variants in <i>TPMT</i> are rare in pediatric acute lymphoblastic leukemia patients from Ethiopia.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"212-217"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288558/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733712","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":"Retrospective Evaluation of Empiric Vancomycin Therapy for Infectious Workups in Relation to Methicillin-Resistant <i>Staphylococcus aureus</i> (MRSA) Risk Factors in the Neonatal Intensive Care Unit.","authors":"Emma Rednour, Brianna Hemmann","doi":"10.5863/1551-6776-30.2.198","DOIUrl":"10.5863/1551-6776-30.2.198","url":null,"abstract":"<p><strong>Objectives: </strong>This study evaluated empiric antibiotic prescribing patterns in relation to methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) risk factors in infants with potential late-onset sepsis (LOS). Secondarily, this study evaluated rates of escalation and de-escalation from initial antibiotic choice in patients who received at least 5 days of therapy.</p><p><strong>Methods: </strong>This was a retrospective study of infants admitted to the neonatal intensive care unit (NICU) from December 1, 2022, to May 31, 2023. Infants at least 3 days old who received antibiotics for an infectious workup were included. The prevalence of risk factors for MRSA, including low birth weight, prematurity, outborn status, length of stay, parenteral nutrition, presence of indwelling lines, and history of MRSA-positive blood culture or colonization, was compared between patients who received vancomycin empirically or an alternative agent.</p><p><strong>Results: </strong>A total of 143 blood cultures were obtained from 95 patients who received antibiotics for an infectious workup during the study period. Group 1 received vancomycin and included 51 (36%) blood cultures. Group 2 received an alternative agent and included 92 (64%) blood cultures. Patients in group 1 had higher rates of every MRSA risk factor included in this study, except for patients who were outborn. Group 1 also averaged a higher total number of MRSA risk factors per patient than group 2 (4.88 vs 2.53; p < 0.001).</p><p><strong>Conclusion: </strong>This institution uses MRSA risk factors to determine empiric antimicrobial therapy in suspected LOS. Further studies are needed to determine the relationship between the studied risk factors and incidence of MRSA infection.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"198-205"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288556/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733713","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}
Hui Wei, Gilbert J Burckart, Perdita Taylor-Zapata, Yun Wang
{"title":"Labeling Pediatric Products: BPCA Efforts and Orphan Drug Opportunities.","authors":"Hui Wei, Gilbert J Burckart, Perdita Taylor-Zapata, Yun Wang","doi":"10.5863/1551-6776-30.2.226","DOIUrl":"10.5863/1551-6776-30.2.226","url":null,"abstract":"<p><strong>Objective: </strong>Although the Orphan Drug Act (ODA) has substantially increased the number of therapies available for rare diseases, there are still unmet needs for drug development in pediatric patients. The current study represents an exploratory collaborative effort from the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) to use publicly available data to advance the assessment of orphan products not fully labeled for pediatric use. We first document the efforts to label drugs for pediatric use by the NIH under the Best Pharmaceuticals for Children Act (BPCA). Then, we explore whether publicly available pediatric data exist for orphan drugs previously identified as not fully labeled for pediatric use.</p><p><strong>Methods: </strong>The NIH BPCA efforts have labeled 20 drugs for pediatric use. We conducted additional analyses of drugs not fully labeled for pediatric use under the ODA for assessment in the relevant pediatric age range using data from published studies.</p><p><strong>Results: </strong>Tafenoquine and miltefosine were identified, and noncompartmental analyses were conducted using published data. Tafenoquine exposures of pediatric patients (2-15 years old) with body weight-based dosing were comparable to the approved patient population with 300 mg daily, along with acceptable variability within the observed subjects. High similarity was also found between studied pediatric patients (2-12 years old) and the approved patient population with the same dose of 2.5 mg/kg/day in the miltefosine exposure-response analysis.</p><p><strong>Conclusion: </strong>Tafenoquine tablets and miltefosine capsules could be considered as additional examples of the BPCA effort to fully label drug products for the pediatric patient population.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"226-238"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288554/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733705","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}
Ugene Sano, Rachel Meyers, Uzma Hasan, Steven Smoke
{"title":"Meropenem/Vaborbactam in Pediatrics: 2 Cases of CRE Intraabdominal Infection.","authors":"Ugene Sano, Rachel Meyers, Uzma Hasan, Steven Smoke","doi":"10.5863/1551-6776-30.2.263","DOIUrl":"10.5863/1551-6776-30.2.263","url":null,"abstract":"<p><p>Meropenem/vaborbactam is a combination antibiotic with a carbapenem and a carbapenemase inhibitor typically reserved for extensively drug-resistant bacterial infections, such as carbapenem-resistant Enterobacterales (CRE). Meropenem/vaborbactam is approved by the United States Food and Drug Administration for use in adults for complicated urinary tract infections, whereas data in the pediatric population are limited. This case series described the use of meropenem/vaborbactam in 2 pediatric patients, ages 11 and 15, with intraabdominal abscesses from CRE. Both patients had clinically improved after the initiation of meropenem/vaborbactam and reported no complications during their follow-up appointments after the completion of their antibiotic courses. These cases demonstrate the safe and effective use of meropenem/vaborbactam in these 2 pediatric patients. Although meropenem/vaborbactam successfully treated both patients' infections, additional data are needed in this population to determine the safety profile and optimal use for pediatric patients.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"263-267"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733706","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}
Mana Sheykhsoltan, Joshua Drobina, Michele M Burns, Erin R Fox, Maryann Mazer-Amirshahi
{"title":"Drug Shortages for Prescription Amphetamine Derivatives.","authors":"Mana Sheykhsoltan, Joshua Drobina, Michele M Burns, Erin R Fox, Maryann Mazer-Amirshahi","doi":"10.5863/1551-6776-30.2.206","DOIUrl":"10.5863/1551-6776-30.2.206","url":null,"abstract":"<p><strong>Objective: </strong>Amphetamine derivatives are first-line medications for attention-deficit/hyperactivity disorder (ADHD). Recently, there have been increasing reports of drug shortages involving amphetamine derivatives. The objective of this study is to describe trends in drug shortages impacting prescription amphetamine derivatives.</p><p><strong>Methods: </strong>Drug shortage data were retrieved from the University of Utah Drug Information Service (UUDIS) from January 2001 to December 2023. Using UUDIS data, we analyzed all reported shortages of amphetamine derivatives, including amphetamine salts, dexmethylphenidate, dextroamphetamine, lisdexamfetamine, and methylphenidate. Specific dosage forms, including extended-release and immediate-release oral preparations and transdermal patch formulations were examined. Data were analyzed focusing on shortage trends over time, specific amphetamine product involved, product formulation, reason for shortage, shortage duration (for resolved shortages), and single source status (made by 1 manufacturer/facility).</p><p><strong>Results: </strong>There were a total of 26 shortages impacting amphetamine derivatives verified by UUDIS from January 1, 2001 to December 31, 2023. The years with the greatest number of amphetamine shortages were 2012, 2013, 2015, and 2023, each with 7 total shortages. The mean shortage duration for resolved shortages was 20.7 months, with a range of 1.3 months to 61.6 months. The longest shortage (61.6 months) was for methylphenidate extended-release tablets. The majority of manufacturers (58%) did not disclose a reason for shortage.</p><p><strong>Conclusions: </strong>Shortages for amphetamine derivatives have increased recently, limiting access to first-line therapy for ADHD. Inaccessibility of these agents can have negative implications for the cognitive development and functioning of children and adolescents, leading to comorbid mental health disorders.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"206-211"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733684","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":"Shielding Our Future: The Need for Innovation in Sunscreen Active Ingredients and Safety Testing in the United States.","authors":"Kelly A Dobos","doi":"10.5863/1551-6776-30.2.286","DOIUrl":"10.5863/1551-6776-30.2.286","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 2","pages":"286-288"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144733714","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}