PMID- 19009550
OWN - NLM
STAT- MEDLINE
DCOM- 20090202
LR  - 20131121
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 18
IP  - 1
DP  - 2009 Jan
TI  - Pediatric drug surveillance and the Food and Drug Administration's adverse event 
      reporting system: an overview of reports, 2003-2007.
PG  - 24-7
LID - 10.1002/pds.1679 [doi]
AB  - PURPOSE: Our objective was to examine the numbers and characteristics of US 
      pediatric adverse events (AEs) reported to the Food and Drug Administration 
      (FDA)'s adverse event reporting system (AERS) for 5 years following 
      implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002. 
      METHODS: We analyzed reports in AERS received by FDA from January 1, 2003 to 
      January 1, 2008 for overall numbers, age, gender, and seriousness of outcome in 
      children and adults. Pediatric and adult age groups (<2, 2-10, 11-17, 18-50, and 
      >50 years of age) were further evaluated for most frequently reported suspect 
      drug classes and AEs. RESULTS: Seventy-two percent of 815 267 crude count reports 
      had specified age information. Six percent of the total reports with age 
      information reported age <18 years. Numbers of AEs being reported for children 
      have remained steady, while those for adults have increased. The proportion of 
      serious AEs reported was similar for pediatrics as compared to adults. Frequently 
      reported suspect drug classes noted in pediatric age groups that were not 
      observed in adults included anticonvulsants, attention deficit hyperactivity 
      disorder (ADHD), anti-acne, and respiratory medications. CONCLUSIONS: This 
      overview highlights the need for strengthening the passive drug surveillance 
      system from a pediatric perspective, as well as investing in more active 
      surveillance systems. Drug safety initiatives to better capture risk information 
      in order to balance the risk/benefit of drug use in children.
FAU - Johann-Liang, Rosemary
AU  - Johann-Liang R
AD  - Health Resources and Services Administration, Department of Health and Human 
      Services, Rockville, MD 20857, USA. Rjohann-liang@hrsa.gov
FAU - Wyeth, Jo
AU  - Wyeth J
FAU - Chen, Min
AU  - Chen M
FAU - Cope, Judith U
AU  - Cope JU
LA  - eng
PT  - Journal Article
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Anticonvulsants)
RN  - 0 (Dermatologic Agents)
SB  - IM
MH  - Acne Vulgaris/drug therapy
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Age Factors
MH  - Anticonvulsants/adverse effects
MH  - Attention Deficit Disorder with Hyperactivity/drug therapy
MH  - Child
MH  - Child, Preschool
MH  - Dermatologic Agents/adverse effects
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Infant
MH  - Middle Aged
MH  - Respiratory Tract Diseases/drug therapy
MH  - Severity of Illness Index
MH  - United States
MH  - *United States Food and Drug Administration
MH  - Young Adult
EDAT- 2008/11/15 09:00
MHDA- 2009/02/03 09:00
CRDT- 2008/11/15 09:00
PHST- 2008/11/15 09:00 [pubmed]
PHST- 2009/02/03 09:00 [medline]
PHST- 2008/11/15 09:00 [entrez]
AID - 10.1002/pds.1679 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2009 Jan;18(1):24-7. doi: 10.1002/pds.1679.