The safety of ibuprofen suspension in children.

Abstract

This paper describes two studies in children with fever in which the safety of ibuprofen was compared with that of paracetamol. The Boston University Fever Study aimed to assess the risk of rare but serious adverse events in febrile children. There were 795 admissions among 84,192 children during the study. There were no significant differences between the drugs in the risk of admission or the risk of secondary endpoints (admissions for asthma or cellulitis, or physician visits for abdominal pain or dyspepsia) and no evidence of clinically significant impairment of renal function. However, ibuprofen was associated with a significantly lower risk of physician visits for asthma: the incidence associated with ibuprofen was 3.0% (CI95% 2.1, 4.1) compared with 5.1% (CI95% 3.5, 7.1) for paracetamol (P = 0.02). The second study was a case control study to investigate a possible association between antipyretic medication, varicella infection and necrotising fasciitis. We identified 52 children aged under 19 years who were admitted to hospital with varicella and Group A streptococcal infection and 172 matched controls with uncomplicated varicella. The risk of invasive Group A streptococcal infection was associated with demographic and environmental factors and persistent high fever. There was no association with the use of ibuprofen or paracetamol alone, but the use of both agents was significantly associated with streptococcal infection. These studies demonstrate that children with fever tolerate treatment with ibuprofen as well as treatment with paracetamol. Neither agent is associated with an increased risk of necrotising soft tissue infections.