TOTAL BILIRUBIN LEVEL IN RELATION TO EXCIPIENTS IN PARENTERAL MORPHINE-SULFATE ADMINISTERED TO SERIOUSLY ILL NEWBORN-INFANTS

We examined exposure to excipients in different morphine sulfate prepa rations in relation to maximum total bilirubin level during the first 5 days of life among 155 infants admitted to a newborn intensive care unit. Sixty-six (43%), 47 (30%), and 42 (27%) newborns were exposed to chlorobutanol, phenol and neither excipient, respectively. Mean maxim um total bilirubin in the first 5 days of life among newborns not expo sed to chlorobutanol or phenol was 10.8 mg/dL (184 mu mol/L). After ad justing for birthweight, race, sex, and use of phototherapy, the maxim um total bilirubin level among newborns exposed to phenol was 1.4mg/dL (24 mu mol/L) higher than the maximum level among newborns exposed to neither excipient (P < 0.05); the corresponding difference associated with chlorobutanol exposure was 1.6 mg/dL (27 mu mol/L) (P < 0.02). F urther adjustment for potential confounding by the major risk factors for hyperbilirubinaemia did not materially change the results. While u nconfirmed, these findings support the growing concern that excipients added to parenteral medications may not be 'inactive' as is often ass umed, and that the safety of such exposures in seriously ill newborn i nfants needs to be studied further.