Abstract
A prospective study on the epidemiology of ADR in the newborn period has been in progress since Feb. 1977. Preliminary analysis of 119 patients whose birth weight (mean and range) was 2563g (450-4535); gestational age 36.0 wks (22-43) who were admitted at 1.9 days, (0.5-65) and hospitalized for 11.5 days (0.5-100 d) revealed 46 ADR in 27 patients (22.7%). Of these, 9 (19.6%) were classified major (fatal or life threatening), 12 (26.1%) moderate, (prolonged hospital stay) and 25 (54.3%) minor Antibiotics and cardiovascular drugs (e.g. priscoline) were the most common drugs associated with ADR. Using Ireys' criteria for the degree of certainty of a drug-reaction association, drugs appeared to be causative in 11 (24%), (8 minor, 1 moderate, 2 major), probable in 6 (13%) (4 moderate, 2 major), possible in 26 (56.5%) and coincidental in 3 (6.5%). The most common moderate to major ADR noted were hypotension, cardiac arrhythmias, renal failure, seizures, GI bleeding. 18 patients exhibited only 1 ADR while 9 had multiple (2-5) ADR. Thirty-three (71.7%) recovered without sequelae, 11 (23.9%) died from existing disease, 1 patient receiving palliative sedation died from respiratory depression. One asphyxiated patient on steroids died from gastrointestinal hemorrhage. The data indicate a high incidence of ADR in sick neonates. The analysis suggests possible approaches to reduce the frequency of ADR.
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Aranda, J., Portuguez-Malavas, A., Collinge, J. et al. 349 ADVERSE DRUG REACTIONS (APR) IN THE NEWBORN INTENSIVE CARE UNIT (NICU). Pediatr Res 12 (Suppl 4), 422 (1978). https://doi.org/10.1203/00006450-197804001-00354
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DOI: https://doi.org/10.1203/00006450-197804001-00354