Safety profile of ibuprofen suspension in young children

Abstract

The Children's Analgesic Medicine Project (CAMP) was a multicenter, all-comers, openlabel, prospective study to compare the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. Four hundred and twenty four (424) pediatricians enrolled 41 810 children (aged 1 month to 18 years old) at 69 US clinics. Safety data included information concerning medication use and adverse events (AEs) summarized by severity and analyzed by age groups (younger and older than 2 years). Among 30 144 children who took at least one dose of ibuprofen or acetaminophen, 14 281 were younger (< 2 yrs) and 15 863 were older ([Symbol: see text] 2 to < 12 yrs). Within both age groups, the incidence rates for specific AEs, including abdominal pain, insomnia, and hyperkinesia were rare and generally < 1% for both treatments. For younger children, fever, vomiting, diarrhea, rhinitis, rash and otitis media were the only AEs with an incidence rate > 1% (in either treatment group). For older children, the only AEs with an incidence rate > 1% in either group were rhinitis, pharyngitis and otitis media. AEs were generally mild to moderate for both treatments within the two age groups. There were no serious AEs, including anaphylaxis, Reye's syndrome, renal failure, GI bleeding/perforation or necrotizing fasciitis. There was a slightly higher overall incidence of side effects in the ibuprofen group (17.6% vs. 15.0%) for the younger children; and similar results were seen in the older children (11.9% vs. 10.7%). This may have been due to the preference of physicians to treat the sicker children with ibuprofen. There were four deaths, all unrelated to study medication, all occurring in children < 2 yrs (herpes encephalitis, sepsis due to 5. pneumoniae, medulloblastoma, and sudden infant death syndrome). The safety of ibuprofen suspension in children < 2 yrs was demonstrated in this study. The safety profile in children < 2 yrs is consistent with the excellent profile observed in children [Symbol: see text] 2 yrs. Overall, ibuprofen exhibited an AE profile similar to acetaminophen in both younger and older children.

Ibuprofen: pharmacology, efficacy and safety

“…As noted earlier in the discussion of the large-scale paediatric study by Ashraf et al (1999) no occurrences of gastric bleeding or ulcers were observed with either ibuprofen or paracetamol. The incidence of adverse events (AEs) in the digestive system was 3.0 and 2.1% in the younger group (B2 years) that received ibuprofen or paracetamol and 2.1 and 1.2% for these drugs in the older group (2-12 years); the statistical tests showed the former being non-significant but in the latter this was statistically significant.…”

“…As noted earlier in the discussion of the large-scale paediatric study by Ashraf et al (1999) there were no occurrences of renal failure or other serious renal conditions observed with either ibuprofen or paracetamol in the groups totalling 31,144 of younger or older children that were analysed.…”

“…However, three cases of erythema multiforme occurred in patients that had received ibuprofen and one that had received paracetamol, thus suggesting that the risks of these events very low . Ashraf et al (1999) in their large scale trial also noted there were no cases of Stevens-Johnson syndrome among their patients.…”

“…Hepatic reactions do not appear to have been reported in any of the large scale hospitalization practitioner based studies in children (Lesko andMitchell, 1995, 1999;Ashraf et al, 1999) or in critical reviews of clinical trails (Rainsford et al 1997(Rainsford et al , 1999. Hepatitis has been frequently reported in trials of NSAIDs including ibuprofen and aspirin in JRA or JIA (Giannini et al 1990) but in the small long-term study Ansell (1973) found that liver function tests were unaltered in these patients.…”

“…Another large investigation into the overall safety of ibuprofen in paediatric populations was performed by Ashraf et al (1999). This study known as the Children's Analgesic Medicines Project (CAMP) was a prospective, multicentre, all-comers, multi-dose, open-randomized and open label study designed to compare the safety of ibuprofen (Children's Advil Ò ) with that of paracetamol (Children's Tylenol Ò ) given for relief of pain and/or fever.…”