Chloramphenicol toxicity in neonates: its incidence and prevention

The incidence of dose related chloramphenicol toxicity was determined in 64 neonates from 12 hospitals. Ten of the 64 exhibited symptoms attributed clinically to chloramphenicol toxicity. Nine received the dose prescribed and one an overdose. Symptoms of the grey baby syndrome were observed in five of the 10 babies; four babies suffered reversible haematological reactions; and one baby was described as very grey. Peak serum chloramphenicol concentrations in these 10 babies ranged from 28 to 180 mg/l and trough concentrations from 19 to 47 mg/l. Serum chloramphenicol concentrations above the therapeutic range (15-25 mg/l) were observed in a further 27 neonates (two had received a 10-fold overdose), none of whom showed signs of toxicity. Serious toxicity was associated with either prescription of dosages greater than that recommended or overdosage of chloramphenicol. High concentrations in young neonates may be avoided by prescribing and giving the recommended dose and then careful monitoring; concentrations should be maintained between 15 and 25 mg/l. No babies with concentrations within this range showed clinical signs of toxicity.