The safety of acetaminophen and ibuprofen among children younger than two years old.
BACKGROUND
Recently ibuprofen has been introduced as a nonprescription analgesic/antipyretic for use in children.


OBJECTIVE
To compare the incidence of serious adverse clinical events among children <2 years old given ibuprofen and acetaminophen to control fever.


METHODS
A practitioner-based, randomized clinical trial. A total of 27 065 febrile children were randomized to receive acetaminophen (12 mg/kg), ibuprofen (5 mg/kg), or ibuprofen (10 mg/kg). Rates of hospitalization for acute gastrointestinal bleeding, acute renal failure, anaphylaxis, Reye's syndrome, asthma, bronchiolitis, and vomiting/gastritis were compared by randomization group.


RESULTS
The risk of hospitalization with any diagnosis in the 4 weeks after enrollment was 1.4% (95% confidence interval, 1. 3%-1.6%) and did not vary by antipyretic assignment. No children were hospitalized for acute renal failure, anaphylaxis, or Reye's syndrome. Three children were hospitalized with gastrointestinal bleeding; all 3 had been assigned to treatment with ibuprofen. The risk of hospitalization with gastrointestinal bleeding among children randomized to ibuprofen was 17 per 100 000 (95% confidence interval, 3.5-49 per 100 000) but was not significantly greater than the risk among children given acetaminophen. The risk of hospitalization with asthma, bronchiolitis, or vomiting/gastritis did not differ by antipyretic assignment.


CONCLUSIONS
The risk of serious adverse clinical events among children <2 years old receiving short-term treatment with either acetaminophen or ibuprofen suspension was small and did not vary by choice of medication. These data do not provide any information on the safety of these medications when used for prolonged periods or when used together, regardless of duration.
Lesko
S M
SM
Slone Epidemiology Unit, Boston University School of Medicine, Brookline, Massachusetts 02446, USA. leskos@bu.edu
Mitchell
A A
AA
D000082:Acetaminophen / Q000009:adverse effects*; D000208:Acute Disease; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects*; D001249:Asthma / Q000139:chemically induced; D001988:Bronchiolitis / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000188:drug therapy; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects*; D007223:Infant; D008297:Male; D012306:Risk; D014839:Vomiting / Q000139:chemically induced
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen; D007052:Ibuprofen