PMID- 24990656
OWN - NLM
STAT- MEDLINE
DCOM- 20150515
LR  - 20140903
IS  - 1875-9114 (Electronic)
IS  - 0277-0008 (Linking)
VI  - 34
IP  - 9
DP  - 2014 Sep
TI  - Drugs associated with adverse events in children and adolescents.
PG  - 918-26
LID - 10.1002/phar.1455 [doi]
AB  - OBJECTIVE: To describe the suspected medications, types of reactions, and 
      outcomes of adverse events (AEs) most commonly reported to the United States Food 
      and Drug Administration (FDA) in children by age group. METHODS: All case reports 
      submitted to the FDA Adverse Event Reporting System (FAERS) between January 1, 
      2007, and August 27, 2012, for children (1 to < 12 yrs) and adolescents (12 to < 
      18 yrs) were examined. The most commonly reported suspected drugs were ranked. 
      The corresponding AEs with serious outcome were compared and described between 
      age groups. RESULTS: We identified a total of 78,623 reports in the FAERS 
      database (53.8% in children and 46.2% in adolescents). Serious outcomes were 
      noted in 40% of the children and 43% of the adolescents. The proportion of all 
      case reports for central nervous system stimulants (lisdexamfetamine, 69.8%; 
      methylphenidate, 68.0%) and analgesics (ibuprofen, 72.3%; acetaminophen, 68.6%) 
      was higher in children, whereas tumor necrosis factor blockers (infliximab, 
      78.2%; adalimumab, 77.1%), atypical antipsychotics (aripiprazole 52.7%; 
      risperidone 58.3%; quetiapine 72.1%) and oral contraceptives (levonogrestrel, 
      99.2%; drospirenone and ethinyl estradiol, 97.9%) were more commonly reported in 
      adolescents. For most drugs, the types of reactions reported were similar but had 
      different rank order across age groups, with the most dissimilar profiles being 
      observed for isotretinoin and aripiprazole. CONCLUSIONS: This study highlights 
      high-risk medications and their AE profiles in children and adolescents. Our 
      findings underscore the need for further confirmation of particular drug and AE 
      pairs and the heterogeneity of AEs by age.
CI  - (c) 2014 Pharmacotherapy Publications, Inc.
FAU - Lee, Wan-Ju
AU  - Lee WJ
AD  - Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, 
      University of Illinois at Chicago, Chicago, Illinois.
FAU - Lee, Todd A
AU  - Lee TA
FAU - Pickard, A Simon
AU  - Pickard AS
FAU - Caskey, Rachel N
AU  - Caskey RN
FAU - Schumock, Glen T
AU  - Schumock GT
LA  - eng
PT  - Journal Article
DEP - 20140703
PL  - United States
TA  - Pharmacotherapy
JT  - Pharmacotherapy
JID - 8111305
SB  - IM
MH  - Adolescent
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Age Factors
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Humans
MH  - Infant
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - adolescents
OT  - adverse events
OT  - children
OT  - heterogeneity
OT  - postmarketing surveillance
EDAT- 2014/07/06 06:00
MHDA- 2015/05/16 06:00
CRDT- 2014/07/04 06:00
PHST- 2014/07/04 06:00 [entrez]
PHST- 2014/07/06 06:00 [pubmed]
PHST- 2015/05/16 06:00 [medline]
AID - 10.1002/phar.1455 [doi]
PST - ppublish
SO  - Pharmacotherapy. 2014 Sep;34(9):918-26. doi: 10.1002/phar.1455. Epub 2014 Jul 3.