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Monographs of fragrance chemicals and extracts that have caused contact allergy / allergic contact dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
In the 1980s, there have been at least 16 fatalities from benzyl alcohol toxicity in neonates in who sodium chloride for injection, containing 0.9% benzyl alcohol as a preservative, had been used for flushing I.V. catheters (68,69,70). It was also present in many parenteral drug formulations (83). In one study of 10 neonates who died (69), before the onset of symptoms, usually around the second to fourth day, all the infants developed progressive metabolic acidosis, the average anion gap at that time being 29 mmol/l (normal 12–18). Slowly progressive bradycardia, often associated with gasping respiration, soon followed (it was also called the ‘gasping syndrome’). Seizures were frequent (eight cases out of ten) and usually developed within 24 hours. The infants became gradually more unresponsive with very depressed EEGs, and eventually they had only reflex movements or occasional gasping respiration. Hypotension leading to cardiovascular collapse was a late finding, usually presaging death. Intracranial hemorrhage was present in six cases. The clinical picture was therefore that of an infant with a severe metabolic acidosis who was unresponsive to treatment and whose symptoms resembled those of a progressive encephalopathy.
The administration of medicines to children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
Benzyl alcohol and benzoate salts may be used as co-solvents or preservatives and may not be tolerated by neonates when metabolism is immature. ‘Gasping syndrome’ and death have been described in neonates treated with intravenous saline preserved with benzyl alcohol [5,6]. Preparations such as lorazepam injection and amiodarone injection contain benzyl alcohol and have been contraindicated for children up to 3 years of age. Use of such excipients is potentially denying useful drugs to this age group.
Antimicrobial prescribing for treatment of serious infections caused by Staphylococcus aureus and methicillin-resistant Staphylococcus aureus in pediatrics: an expert review
Published in Expert Review of Anti-infective Therapy, 2021
Sean N. Avedissian, Nathanial J. Rhodes, Christopher L. Shaffer, Lan Tran, John S. Bradley, Jennifer Le
Linezolid is an oxazolidinone antibiotic, with wide antibacterial activity against gram-negative and gram-positive organisms, including MRSA, originally studied for treatment of multidrug resistant pneumococci before the widespread use of protein-conjugated pneumoccal vaccines. Linezolid is a unique MRSA treatment option since it demonstrates 100% bioavailability with extensive distribution to most tissue; thus, it can be administered orally (PO) as well as intravenously (IV). Initially used for pediatric patients with skin and soft tissue infections with its oral formulation, linezolid has been utilized as a treatment for serious MRSA infections in children spanning neonates through adolescents. Linezolid 10 mg/kg/dose (PO/IV) every 8–12 hours may be useful as an alternative therapy in pediatric patients with acute hematogenous MRSA osteomyelitis, pneumonia, CNS-related infections, bacteremia and sepsis. To date, there have been approximately 11 published clinical trials and 60 case series of linezolid use in pediatric patients. A summary of these studies can be found in an article by Garazzino and Tovo [40]. Several pediatric clinical studies that evaluated patients with MRSA have demonstrated clinical success comparable to standardized vancomycin dosing [41,42]. Microbiologic eradication occurred in 90% of pediatric patients with MRSA skin and skin structure infections and was slightly lower (88%) in neonates. Linezolid appears to be well tolerated in pediatric patients, with less bone marrow suppression as compared to adults. It should be noted that the oral suspension contains sodium benzoate; therefore, prolonged use of the oral product in neonates should be monitored for ‘gasping syndrome’.
Possible effects of excipients used in the parenteral drugs administered in critically ill adults, children, and neonates
Published in Expert Opinion on Drug Safety, 2020
Kannan Sridharan, Hasan MSN Hasan, Muna Al Jufairi, Amal Al Daylami, Eman Al Ansari, Ali Mohammed Qader, Sheikh Abdul Azeez Pasha
Use of excipients in the pediatric population is different from that used in adults especially in oral formulations so as to have an improved palatability. Similarly, as the excipients are metabolized and are excreted from the body, the parenteral preparations used in children especially in neonates are supposed to have modifications compared to the adult formulations. The E-ferol incident where neonates died following injection of vitamin E has thrown lights on the use of polysorbate, a widely used excipient in parenteral preparations [9]. The use of benzyl alcohol in neonates resulted in ‘acute gasping syndrome’ and consequently death [10]. The difference in certain metabolic pathways due to organ immaturity particularly glycine conjugation of benzoic acid (the metabolite of benzyl alcohol) to form hippuric acid results in the neonatal gasping syndrome [11]. Newborns are exposed to almost 60 different excipients used in medicines [12]. Surprisingly, review of a hospital treatment’s guide in Spain revealed that nearly 25% of the intravenous preparations and 19% of oral drugs used in children contained toxic excipients exceeding the accepted daily intake in adults [13]. Valeuret al have estimated a maximal daily exposure to ethanol (1563 mg/kg/day) and propylene glycol (954 mg/kg/day) that exceeded the tolerance limits recommended by European Medicines Agency by 261 and 19 times respectively [14]. Another study conducted in 89 neonatal units in 21 European nations concluded that around 43% of their study population received at least one of potentially harmful excipients [15]. Lass et al in Estonia and Souza et al from Brazil have also observed that almost all the neonates received medicinal product containing one of the harmful excipients [16,17]. Recently, United States and European Union pediatric formulation initiatives have established a collaborative database named STEP (Safety and Toxicity of Excipients for Pediatrics) based on a systematic organization of information on the safety of each excipient used in children [2]. Hence, we carried out the present study to assess the excipients present in the parenteral preparations used in adult, pediatric, and neonatal intensive care units.