OBJECTIVE Enoxaparin is regularly used to treat thromboembolism in children. Numerous retrospective studies suggest that infants and young children require higher enoxaparin doses to achieve therapeutic anti-factor Xa (AXA) concentration of 0.5 to 1.0 units/mL compared with adults. METHODS This is a retrospective analysis of pre- and post-implementation of an increased initial dose of enoxaparin (1.2 mg/kg every 12 hours) for infants between 2 and 6 months of age. The objective is to compare the number of dose adjustments needed to achieve therapeutic AXA. RESULTS A total of 64 patients were included 30 pre- and 34 post-guideline groups. In both the pre- and post-guideline dosing groups the number of dose adjustments required to achieve therapeutic AXA when adjusted per the ACCP guidelines was a median of 1 (p = 0.35). However, the first initial AXA was 0.3 units/mL in the pre-guideline group and 0.48 units/mL in the post-guideline group (p = 0.07). There were no documented instances of major bleeding events in either group. CONCLUSION The results support the recommendation of an increased enoxaparin starting dose for therapeutic anticoagulation in the described patient population at the study site. A large prospective study is needed to determine specific dose recommendations that will achieve therapeutic AXA concentrations for the majority of infants and children of all ages.
Neonatal invasive fungal infections (IFI) from Aspergillus species are increasing in frequency. While voriconazole remains the antifungal of choice for treatment in many patient populations, several pharmacokinetic challenges affect dosing of voriconazole in premature neonates. Further complicating voriconazole use are the unknown implications of drug interactions in the preterm population. We report a case of voriconazole use in a neonate for the treatment of cutaneous Aspergillosis with variable serum voriconazole concentrations, reflecting a suspected drug interaction with dexamethasone. Serum voriconazole concentrations were initially subtherapeutic despite multiple dose escalations, then unexpectedly increased to supratherapeutic range as a concomitant dexamethasone course was tapered. Re-initiation of voriconazole after discontinuation of dexamethasone resulted in supratherapeutic concentrations that were discordant from previous serum concentrations on the same voriconazole dose while receiving dexamethasone. This is the first report of a potential drug interaction between voriconazole and a corticosteroid in a preterm neonate, highlighting the importance of drug interactions in voriconazole dosing evaluation and monitoring in this population.
OBJECTIVES:Propofol is used sparingly in pediatrics owing to the risk of propofol-related infusion syndrome (PRIS). The objective of this study is to evaluate the safety of propofol in pediatrics and describe its effectiveness at facilitating extubation and decreasing concomitant sedation. METHODS:This retrospective, descriptive study evaluated critically ill children who received continuous propofol infusions for at least 12 consecutive hours while admitted to pediatric, congenital cardiac, or neonatal intensive care units. The primary outcome was PRIS incidence. Secondary outcomes included change from baseline in laboratory parameters, discontinuation due to adverse effects, change in sedative requirements following sedation washout, and successful extubation. RESULTS:From January 1, 2019, to November 1, 2023, a total of 100 children received 120 courses of propofol infusions. The median infusion rate was 106 mcg/kg/min (IQR, 68-149) and 27.5% of courses exceeded 48 hours in duration. No PRIS events were identified. Patients experienced a moderate, non-duration-dependent increase in triglycerides, with no impact on aspartate aminotransferase (AST)/alanine aminotransferase (ALT) concentrations; 11.7% of infusions were discontinued for adverse effects. No children self-extubated while on propofol when used for peri-extubation (N = 49). Opioid and benzodiazepine requirements were decreased by 17% and 26% from baseline, respectively, during a 24-hour period following sedation washout (N = 26). CONCLUSIONS:Propofol was tolerated by most patients at doses commonly exceeding guideline-recommended maximum rate and duration. Propofol was safely used to facilitate extubation and decreased baseline sedative exposure when used for sedation washout in a complex critically ill pediatric population.
OBJECTIVE To assess prescribing patterns following an oral cephalosporin formulary change and the implementation of a legacy medication alternative in the electronic medical record to discourage prescribing cefdinir when de-escalating intravenous ceftriaxone to an enteral antibiotic in pediatric patients. METHODS This was a single-center, retrospective cohort study of hospitalized pediatric patients who received at least 1 dose of ceftriaxone de-escalated to an enteral antibiotic for the treatment of community-acquired pneumonia, upper respiratory tract infection, or urinary tract infection. Patients from a 6-month period post-formulary change were compared with a historical cohort from the same timeframe, 1 year prior. The primary outcome was the change in cefdinir prescribing. Secondary outcomes included the rate of optimal antibiotic de-escalation before and after the interventions, hospital length of stay, and hospital re-encounter rates. RESULTS A total of 134 patients were included. Cefdinir prescribing occurred in 44% and 34% (p = 0.287) of patients pre- and post-intervention, respectively. Optimal enteral antibiotic de-escalation occurred in 46 (62%) patients pre-intervention and 43 (72%) post-intervention (p = 0.245). Rates of optimal de-escalation were lowest for patients treated for urinary tract infection (< 60% in both cohorts), with cefdinir used in 48% of these cases. Hospital re-encounters occurred in 6 (8%) patients pre-intervention and 0 (0%) post-intervention (p = 0.035). Median length of stay was significantly reduced (p = 0.038) post-intervention, driven by a 1-day reduction in patients treated for community-acquired pneumonia (p = 0.013). CONCLUSIONS After the formulary changes involving cefdinir, there was no significant decrease in cefdinir use or in optimal de-escalation rates. There were significantly lower hospital re-encounters and shorter lengths of stay, though further studies are needed to validate these findings.
BACKGROUND The pediatric drug development landscape has experienced major shifts, largely in response to legislative and regulatory initiatives. However, associated laws and guidance documents fail to mandate the manufacture of pediatric formulations for commercial marketing post-regulatory approval. This study explores the nature of commercial products available at the time of pediatric labeling. METHODS All orally administered drugs for which labeling changes were made from 1998-2024 were evaluated. Characteristics of each drug’s commercially marketed formulation(s) at the time of labeling were identified using product labeling (Drugs@FDA), Drugs.com, and DailyMed. RESULTS During the timeframe reviewed, there were 611 unique labeling changes representing 425 unique drugs available as 567 commercially marketed formulations. Of these drugs, 188 were marketed with pediatric-friendly (PF) formulations. The remainder were available only as solid oral dosage forms. For 329 pediatric labeling changes (53.8%), the only commercially marketed formulation was a solid oral dosage form, in many cases at sizes exceeding reasonable thresholds for the age group. For the remaining 282 labeling changes, a PF formulation was available alone or as a companion to the adult formulation. Among the PF formulations, 62% were suited to direct administration (liquid, orodispersible tablet, chewable/paste, transmucosal) while the remainder required manipulation (i.e. powder/granule, sprinkle/pellet, dispersible tablet). Three-fourths of the PF formulations incorporated flavorings and aromas though 13% failed to report the use of sweeteners. CONCLUSIONS Less than complete access to PF formulations requires attention if we are to maximize the provision of suitable pharmacotherapy for pediatric patients.
OBJECTIVE:Sickle cell disease (SCD) is associated with altered renal function, particularly glomerular hyperfiltration, which may increase vancomycin clearance and result in subtherapeutic drug exposure. Limited data exist on vancomycin pharmacokinetics in non-ICU pediatric SCD patients. The objective of this research is to compare vancomycin trough concentrations and dosing requirements between pediatric patients with and without SCD. METHOD:A retrospective cohort study compared two groups-pediatric non-ICU patients with SCD (n=29) and without SCD (n=58)-assessing initial and repeated trough concentrations, dosing regimens, and renal function. The data was collected over 10-year (2014-2024). RESULTS:Among the 87 included patients, 29 were SCD patients and 58 were without SCD Initial serum vancomycin trough concentrations were significantly lower in SCD patients compared to non-SCD patients (5.43 ± 2.61 vs. 10.62 ± 4.71 mg/L; p < 0.00001). Despite dose adjustments, troughs remained lower in SCD patients (10.30 ± 3.61 vs. 13.10 ± 3.73 mg/L; p = 0.0023). SCD patients required higher adjusted doses (64.2 ± 10.0 vs. 58.3 ± 12.0 mg/kg/day). Multiple regression confirmed SCD status as an independent predictor of lower trough concentrations (β = -4.40; p < 0.001). CONCLUSION:Pediatric patients with SCD exhibit significantly lower serum vancomycin trough concentrations and require higher dosing to achieve therapeutic target concentrations. Early therapeutic drug monitoring and individualized dosing strategies are recommended to minimize subtherapeutic exposure and optimize antimicrobial efficacy in this high-risk population.
OBJECTIVE Laparoscopic appendectomy is the primary treatment of appendicitis, but multimodal pain regimens are necessary to improve postoperative outcomes and optimize pain control. There are limited data comparing the analgesic requirements between perforated and non-perforated appendicitis and whether perforation requires more opioids due to its complications. The objective of this research is to compare the quantity of opioid administrations in perforated and non-perforated appendicitis following laparoscopic appendectomy to see if there is a difference in analgesic requirements. METHODS This retrospective, cohort study included pediatric patients that underwent laparoscopic appendectomy for perforated and non-perforated appendicitis. Patients were evaluated from May 4, 2024 through December 31, 2024. The number of administrations of opioids, acetaminophen, and non-steroidal anti-inflammatory drugs were evaluated with binary χ 2 test and Mann-Whitney U test. RESULTS A total of 60 patients were included, with 30 perforated appendicitis and 30 non-perforated appendicitis. Opioids were administered in 50% of perforated and 56.7% of non-perforated appendicitis patients (p = 0.79). A negative binomial regression showed perforated patients administered opioids received 1.58 times the number of opioid administrations on average (p = 0.19) and for each additional year of age, the expected number of opioid administrations increased by 11% (p = 0.05). The median number of non-opioid analgesic administrations were statistically significant in perforated appendicitis patients versus non-perforated, with 2.5 acetaminophen administrations versus 1 (p = 0.002) and 8 NSAID administrations versus 1 (p < 0.001). CONCLUSIONS The number of opioids administered were similar across groups, but perforated appendicitis patients utilized more acetaminophen.
OBJECTIVE:The management of cystic fibrosis (CF) requires intensive, chronic medication regimens that can have a high treatment burden and cost. De-escalation of chronic medications for patients with CF aged 12 years and older on elexacaftor-tezacaftor-ivacaftor (ETI) has been evaluated; however, data are lacking for patients aged 6 to 11 years. METHODS:This single-center, retrospective study evaluated the non-inferiority of chronic medication de-escalation following an institutional algorithm in children 6 to 11 years with CF by comparing the difference in percent predicted FEV1 (ppFEV1) at 3 to 12 months after ETI initiation. Children with CF who had at least 1 copy of F508del and were started on ETI between January 1, 2021, and December 31, 2022, were included. Secondary outcomes included changes in the number of chronic inhaled CF medications, presence of Pseudomonas on a sputum culture, CF-related hospitalizations, and body mass index (BMI) z-score. RESULTS:Forty-one patients were included. The sample's baseline mean ppFEV1 was 95%. The mean difference in ppFEV1 between month 3 and month 12 on ETI was -1.37% (95% CI, -5.33 to 2.6). The lower bound of the 95% CI was less than the pre-defined non-inferiority margin (NIM) of -3.0%. Half of the patients had zero chronic inhaled medications by month 12 on ETI. Any Psuedomonas decreased from 27.5% to 7.5% (p = 0.037) 1 year post-ETI initiation. CONCLUSIONS:Following the initiation of an institutional medication de-escalation algorithm, the number of chronic medications in children aged 6 to 11 years with CF on ETI was decreased. However, this study was unable to confirm the non-inferiority of chronic medication de-escalation in this younger population with CF.
The most common type of tachyarrhythmia in neonates is supraventricular tachycardia (SVT), which affects 1:250 to 1000 children and usually appears in the first year of life. Although some patients are asymptomatic, others may present with poor feeding, rapid breathing, and irritability. If left untreated, the condition can progress to heart failure and cardiogenic shock. This report describes a 20-day-old male neonate who developed SVT while receiving oseltamivir treatment for influenza and recovered with adenosine treatment. It also highlights the importance of avoiding possible triggers, early diagnosis, and treatment of SVT in neonates.
The rise of antibiotic-resistant bacteria has reignited global interest in bacteriophages as potential therapeutic agents. Bacteriophage (phage) therapy provides an alternative to conventional antibiotics to treat serious infections caused by multidrug-resistant pathogens. In this narrative review, we explore the pharmacokinetics (PK), pharmacodynamics (PD), and clinical use of phage therapy in pediatric populations. We conducted PubMed searches for relevant publications from 1959 to September 2025. In contrast to most drugs, phages are self-replicating in the presence of target bacteria, necessitating the use of non-linear, dynamic pharmacology models to integrate phage-bacteria interaction (which can fluctuate over time, based on the presence of susceptible bacteria), as well as host factors such as immune clearance of phages and traditional host mechanisms of clearance of invasive bacterial pathogens. Phages are primarily cleared through the reticuloendothelial system, particularly in the liver and spleen. Advantages of phage therapy over antibiotics include a promising safety profile, preservation of the child’s own microbiome, and, compared with some antibiotics, enhanced penetration into biofilms. Our knowledge of the benefits and risks of phage therapy is limited largely to current pediatric case reports and case series. The clinical use spans a wide breadth of clinical infections, mostly involving poorly responsive infections caused by multidrug-resistant bacteria. Until robust, prospective PK-PD and clinical trial data become available to guide therapy, phage therapy should be administered under protocols with individualized dosing and rigorous safety monitoring. Clinical applications using standardized, evidence-based dosing regimens and outcome assessments require further evaluation.
The aim of the study was to analyze the cellular and humoral mechanisms underlying the development of allergic laryngitis, to identify key diagnostic markers, and to evaluate the effectiveness of contemporary therapeutic approaches. The study examined the principal pathogenetic mechanisms of the disease, with particular emphasis on the Th2-mediated immune response, the role of cytokines IL-4, IL-5, and IL-13 , immunoglobulin E (IgE), and mast cell degranulation, as well as current diagnostic methods, including laryngoscopy, skin testing, spirometry, and immunological assays. The findings confirm the leading role of Th2-dependent inflammation and IgE-mediated reactions in the development of laryngeal inflammation. The study concludes that allergen-specific immunotherapy combined with antihistamines and inhaled glucocorticosteroids is highly effective in improving symptom control and reducing the risk of relapse, supporting the integration of immunological markers and instrumental diagnostic methods to enhance diagnostic accuracy and enable personalized treatment strategies.
An often overlooked yet increasingly important factor in selecting appropriate medication therapy is a patient’s genetic makeup. The primary goal of implementing a pharmacogenomics program is to reduce the risk of adverse drug reactions and decrease the risk of therapeutic failures. With recent technological advances, decreased cost of testing, and availability of pharmacogenomic guidance, pre-emptive pharmacogenomic testing has become more accessible and practical. Our institution’s initiative to implement a clinical pharmacogenomics program reflects a broader commitment to advancing personalized medicine. We outline the processes and strategies employed to implement a pharmacogenomics service within a free-standing pediatric community hospital, with a pilot program focused on pediatric oncology patients. Various factors must be considered when implementing a pharmacogenomics program not limited to gene identification, laboratory selection, and technology integration. As the field continues to advance, our experience highlights the importance of adaptability, continuous learning, and a patient-centered approach to maximize the benefits of personalized medicine in pediatric care.
Cosmetic use among preteens and adolescents is increasingly common, fueled by social media trends and marketing campaigns that blur the lines between childhood innocence and adult beauty culture. Although these products are often marketed as safe, many contain chemicals of concern, including endocrine-disruptions agents, allergens, and potential carcinogens. Early and prolonged exposure during critical stages of growth raises important questions about immediate and long-term health consequences. Children and teenagers are particularly vulnerable because their skin barrier is thinner and more permeable than that of adults, allowing greater absorption of harmful substances. Endocrine-disrupting chemicals interfere with normal hormonal pathways, potentially altering physical development and reproductive health. Fragrances and preservatives may provoke allergic or irritant reactions, leading to dermatologic conditions such as contact dermatitis and acne exacerbation. Cumulative exposure over years may also increase the risk of cellular damage or malignancy. Beyond physical effects, cosmetic use during adolescence carries psychosocial implications. Engagement with appearance-focused products reinforces unattainable beauty ideals, heightens self-consciousness, and may increase anxiety, body dissatisfaction, and eating-disorder behaviors. These risks are amplified by advertising practices that emphasize perfection while concealing potential harms. Strengthening regulation, ingredient transparency, age-specific safety testing, and public health education is needed to safeguard adolescent well-being.
Clinicians are often faced with the dilemma of having to decide if a drug is safe for a mother to take while she is breastfeeding her infant. This is particularly difficult with a relatively new drug because information on breastmilk excretion or use during lactation is rarely available. This article reviews the measures used to assess the safety of drugs during breastfeeding and provides some practical guidance on their use.
