PMID- 17638093
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20100112
LR  - 20220716
IS  - 0925-4692 (Print)
IS  - 0925-4692 (Linking)
VI  - 7
IP  - 3
DP  - 1999
TI  - Safety profile of ibuprofen suspension in young children.
PG  - 219-25
AB  - 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.
FAU - Ashraf, E
AU  - Ashraf E
AD  - Whitehall-Robins Healthcare, 5 Giralda Farms, 07940-0871, Madison, NJ, USA.
FAU - Ford, L
AU  - Ford L
FAU - Geetha, R
AU  - Geetha R
FAU - Cooper, S
AU  - Cooper S
LA  - eng
PT  - Journal Article
PL  - Switzerland
TA  - Inflammopharmacology
JT  - Inflammopharmacology
JID - 9112626
EDAT- 2007/07/20 09:00
MHDA- 2007/07/20 09:01
CRDT- 2007/07/20 09:00
PHST- 1999/08/09 00:00 [received]
PHST- 1999/08/18 00:00 [accepted]
PHST- 2007/07/20 09:00 [pubmed]
PHST- 2007/07/20 09:01 [medline]
PHST- 2007/07/20 09:00 [entrez]
AID - 10.1007/s10787-999-0005-0 [doi]
PST - ppublish
SO  - Inflammopharmacology. 1999;7(3):219-25. doi: 10.1007/s10787-999-0005-0.