Neonates exposed to excipients: concern about safety

Excipients are generally perceived as inert and pharmacologically inactive. Instead, serious adverse reactions have been reported in vulnerable patient populations and little is known about exposure of newborns to excipients. The aim of this review is to deepen the presence of potentially harmful excipients in drugs commonly used in neonates. From an analysis of articles and case reports present in the international literature emerges that several medicines administered to newborns contain potentially harmful excipients such as ethanol, propylene glycol and benzyl alcohol. Neonatologists should be aware of this problem and possibly prescribe substitutive treatments

Antibiotic Use in a Cohort of Extremely Low Birth Weight Neonates: Focus on Off-Label Uses and Prescription Behaviour

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Pharmacological treatment of ceftriaxone-related cholelithiasis in children: is it worthwhile?

Ceftriaxone treatment of bacterial infections can be associated with biliary complications, more commonly in children than adults, in a dose-dependent manner. This study describes a clinical case series of children with ceftriaxone-related cholelithiasis. We performed a retrospective analysis of cases of ceftriaxone-related biliary complications admitted to the Pediatric Clinic, Department of Clinical and Experimental Medicine, University of Sassari, Italy, during the period 2005-2015. Four children with cholelithiasis occurring during, or soon after, the treatment with ceftriaxone are reported. Case 1 (6-month-old), case 2 (9-year-old) and case 4 (10-year-old) were symptomatic, while case 3 (3-year-old) was asymptomatic. After the ultrasonographic diagnosis of gallstones (cases 1 and 2) or biliary sludge (cases 3 and 4), ceftriaxone treatment was withdrawn, and ursodeoxycholic acid (UDCA) was started in cases 1 and 2. A complete recovery was observed in all but case 1, in whom cholelithiasis was still detectable at one-year follow-up by ultrasonography. This case underwent a triple antibiotic protocol for bacterial meningitis. The protocol included rifampicin, which is known to have an effect in decreasing hepatic concentration of bile salts. Therefore, in this case, both rifampicin and UDCA were of no benefit in preventing or treating ceftriaxone biliary complications. The current pharmacological approach for the treatment of ceftriaxone-related cholelithiasis seems to be ineffective, likely due to the high calcium content of gallstones. Therefore, the best strategy of intervention for ceftriaxone biliary complications in children remains the prevention of the risk factors

Variability in drug use among newborns admitted to NICUs: a proposal for a European multicentre study

The use of drugs in newborns admitted to NICUs is characterized by a great variability. This widespread phenomenon, observed both within and between different countries, has been highlighted by reporting data on the treatment of neonatal sepsis and PDA throughout Europe: the dosages and the intervals between administrations of ciprofloxacin and fluconazole varied significantly and a wide variation was also observed as regards the use of NSAIDs to treat PDA. Given the unique characteristics of the neonatal population, the use of drugs on an individual basis could be sometimes justified. However, other factors such as the lack of evidence-based guidelines and the common use of drugs in an off-label manner (more than 80% of newborns receive this kind of treatment) could contribute to the variability in medicine use, making the neonatal population vulnerable to adverse drug reactions (ADRs) and medication errors: the potential ADRs rate, 3 times higher in pediatric wards, is more significantly higher in NICUs and the frequency of medication errors (mostly dose errors) widely exceeds the medium value. The differences in clinical practices observed between NICUs need to be addressed at a European level and a multicentre study could be useful to harmonize drug use in newborns

Antibiotics and antifungals in VLBW infants

Very low birth weight infants are particularly vulnerable to bacterial and fungal infections. This leads to a common use of antiinfectives, often on a prophylactic basis. Due to the limited available information and the lack of guidelines, the use of antibacterials and antifungals in preterm newborns admitted to Neonatal Intensive Care Units is characterized by a large variability and these drugs are frequently given with different modalities, particularly as regards dosage and frequency, and in an off-label manner. This article provides an updated overview of the current situation on the use of antiinfectives in prematures, by reporting information derived by an analysis of the literature

Farmaci, bambini e COVID-19

A partire da dicembre 2019, quando \ue8 stato segnalato il primo cluster a Wuhan (Cina), l'infezione da COVID-19 si \ue8 diffusa a livello globale. Nella popolazione pediatrica, i casi finora riportati sono relativamente limitati, si presentano con quadri clinici spesso pi\uf9 lievi e i decessi sono rari. Anche in Italia i dati a disposizione sembrano confermati, con circa un 15% di casi severi, dove la presenza di pi\uf9 patologie e un'et\ue0 inferiore ai 6 mesi sembrano giocare un ruolo determinante. La gestione clinica \ue8 fondamentale e basata su una terapia di supporto e sul trattamento delle complicanze. Nel bambino, il trattamento \ue8 sintomatico nei casi lievi, mentre nei casi pi\uf9 gravi \ue8 prevista una terapia di supporto respiratorio e delle funzioni d'organo. Inoltre, diversi farmaci possono essere utilizzati con modalit\ue0 off-label con l'intento di inibire la replicazione virale e di attenuare la risposta infiammatoria: principalmente agenti antivirali, interferone, corticosteroidi e immunoglobuline.. t

Drug metabolizing enzymes in the perinatal and neonatal period: differences in the expression and activity

Physiological changes occurring perinatally and in the first month of life can affect the answer to a pharmacological treatment and the individual response to a drug in terms of efficacy and toxicity is highly variable in the neonatal population. Among potential causes for such variability, differences in drug metabolism may have a great impact. This article aims to review qualitative and quantitative differences in drug metabolizing enzymes in neonates, since both phase I and phase II metabolic pathways are immature at birth and subject to maturational changes in the first period of extrauterine life. Moreover, clinical implications will be discussed

Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study

The use of medicines among newborns admitted to intensive care units is characterized by a high prevalence of off-label/unlicensed use and a wide variability in the absence of international guidelines. A prospective cross-sectional study was organized with the aim to analyse drug prescriptions among all 107 Italian level III neonatal intensive care units

L'utilizzo dei preparati fitoterapici: tendenze emerse da interviste svolte nella provincia di Verona

L'articolo presenta i risultati di un'indagine esplorativa volta a verificare, in un campione di cittadini veneti, la conoscenza e la diffusione dei preparati fitoterapici, le modalit\ue0 del loro utilizzo, l'influenza da parte di informatori non medici e i risultati osservati in termini di efficacia, tollerabilit\ue0 e livello di soddisfazion

Prodotti fitoterapici nel bambino: considerazioni sul loro uso e possibili rischi

I fitoterapici, come i farmaci tradizionali, possono potenzialmente rappresentare un rischio se assunti dai bambini senza adeguata sperimentazione e senza adeguato controllo medico. Dal momento che indagini sistematiche sulla sicurezza di questi prodotti praticamente non esistono, nell'articolo vengono presentati i dati della letteratura internazionale disponibili, in particolare riportando i case reports di effetti indesiderati severi riscontrati in bambini dopo l'assunzione di prodotti fitoterapici, e la situazione italian