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Potentially Harmful Manufacturing Excipients Found in Neonatal Oral Antimicrobials: Presented at ESPID By Jenny Powers THE HAGUE, Netherlands -- June 13, 2011 -- During a press conference here on June 10 at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), attendees were alerted to the possible presence of toxic excipients in oral antimicrobials used in neonatal care hospital units throughout the United Kingdom. Some excipients have been associated with neonatal morbidity and mortality, but the extent of exposure to excipients from antimicrobials has not yet been determined. Marc Turner, PhD, Women’s and Children’s Health Department of the University of Liverpool, Liverpool, United Kingdom, and colleagues conducted a survey of neonatal care units throughout the United Kingdom, asking each unit to report how many babies received medicines during any given 2-week period. A total of 31 units responded and reported that 642 prescriptions for enteral medications were prescribed to infants. The excipient content could be identified in 64 distinct products by using informative material in the public domain and by information obtained from manufacturers; 16 (25%) of these products were antimicrobials. It was found that these antimicrobials contained 30 different taste enhancers and/or colourants and 10 agents used to modify chemical or physical properties of the formulation. A total of 12 antimicrobial contained 9 separate excipients that were potentially harmful because they are metabolised by pathways that are immature in neonates or known to be harmful in neonates. Dr. Turned concluded that 75% of enteral antimicrobial preparations currently used in UK neonatal units contain additives that have been identified as being potentially toxic and stressed that further study is needed to determine the full extent of excipient exposure among neonates and to identify instances in which reformulation should be required. No external funding was reported for this study. [Presentation title: Potentially Toxic Excipients Are Found in Oral Antimicrobial Agents Used in UK Neonatal Units. Abstract 826] E-mail this page to a friend or colleague! To print, use this version