Background The information on neonatal exposure to excipients is limited. Previous studies have focused on the excipients known to be toxic, but have not evaluated the general extent of excipient use or assessed the potential neonatal toxicity of excipients.
Purpose To classify the excipients administered into categories according to the possible toxicity to neonates; to record the extent of inpatient neonatal exposure to potentially harmful excipients; and to assess the quantities of toxic excipients in used medicines.
Materials and methods A prospective cohort study recorded all drugs prescribed to neonates hospitalised in Tartu University Hospital from 01.02-01.08 2008 and in Tallinn Children's Hospital from 01.02- 01.08 2009. Excipients were recorded from the Summaries of Product Characteristics and divided into categories by literature review – potentially harmful (likely to be toxic, known toxicity as a substance / as an excipient); unlikely to be toxic; non-toxic; no safety data found; description too unspecific.
Results 348 neonates received 1961 prescriptions for 107 drugs of which 1620 (83%) contained 123 excipients, 41 of them potentially harmful to neonates. Most neonates (89%) received at least one drug with potentially harmful excipients; exposure was similar in preterm and term neonates – median 2 (range 1 to 15) and 1 (range 1 to 11), respectively. Parabens and sodium metabisulfite were the most commonly used potentially harmful excipients, received by 343 and 297 neonates, respectively. Of all medicines 67% contained at least one potentially harmful excipient, average 1.45 (max 5) per drug. The most common medicines with potentially harmful excipients were parenteral gentamicin and oral simethicone, 200 and 108 prescriptions, respectively.
Conclusions Hospitalised neonates are exposed to significant amounts of potentially harmful excipients. Information about excipients should be made more available to pharmacists and treating physicians to help to evaluate neonatal drug safety.
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