메뉴 건너뛰기




Volumn 18, Issue 1, 2009, Pages 24-27

Pediatric drug surveillance and the food and drug administration's adverse event reporting system: An overview of reports, 2003-2007

Author keywords

Adverse events; Children; Drug safety; Drug surveillance; Pediatric; Reporting

Indexed keywords

ANTI ACNE AGENT; ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; ANTIINFECTIVE AGENT; ANTIRETROVIRUS AGENT; CONTRACEPTIVE AGENT; CYCLOOXYGENASE 2 INHIBITOR; HISTAMINE H2 RECEPTOR ANTAGONIST; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IMMUNOMODULATING AGENT; INTERFERON; MONOCLONAL ANTIBODY; NEUROLEPTIC AGENT; OPIATE; RESPIRATORY TRACT AGENT; DERMATOLOGICAL AGENT; DRUG;

EID: 59049100725     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1679     Document Type: Review
Times cited : (44)

References (14)
  • 1
    • 84889452671 scopus 로고    scopus 로고
    • Ahmad SR, Goetsch RA, Marks NS. Spontaneous reporting in the United States. In Pharmacoepidemiology, 4th ed. Strom BL (ed.). John Wiley and Sons, Ltd: Chichester, UK, 2005; 135-159.
    • Ahmad SR, Goetsch RA, Marks NS. Spontaneous reporting in the United States. In Pharmacoepidemiology, 4th ed. Strom BL (ed.). John Wiley and Sons, Ltd: Chichester, UK, 2005; 135-159.
  • 2
    • 2942588779 scopus 로고    scopus 로고
    • Peripheral neuropathy in patients treated with leflunomide
    • Bonnel RA, Graham DJ. Peripheral neuropathy in patients treated with leflunomide. Clin Pharmacol Ther 2004; 75(6): 580-585.
    • (2004) Clin Pharmacol Ther , vol.75 , Issue.6 , pp. 580-585
    • Bonnel, R.A.1    Graham, D.J.2
  • 3
    • 61449230832 scopus 로고    scopus 로고
    • Best Pharmaceuticals for Children Act. Pub.L. No. 107-109 (Jan 4, 2002) http://www.fda.gov/opacom/laws/pharmkids/contents.html (accessed 8 May 2007).
    • Best Pharmaceuticals for Children Act. Pub.L. No. 107-109 (Jan 4, 2002) http://www.fda.gov/opacom/laws/pharmkids/contents.html (accessed 8 May 2007).
  • 4
    • 61449152997 scopus 로고    scopus 로고
    • FDA Office of Pediatric Therapeutics, Rockville;, accessed 8 May 2007
    • FDA. Pediatric Advisory Committee meetings. FDA Office of Pediatric Therapeutics, Rockville; 2006. http://www.fda.gov/oc/opt/ PACmeetings.html (accessed 8 May 2007).
    • (2006) Pediatric Advisory Committee meetings
  • 6
    • 61449212160 scopus 로고    scopus 로고
    • Vector One®: National [electronic database]. Yardley (PA): Verispan, LLC. Years 2002-2007, Extracted March 2008.
    • Vector One®: National [electronic database]. Yardley (PA): Verispan, LLC. Years 2002-2007, Extracted March 2008.
  • 8
    • 51649091488 scopus 로고    scopus 로고
    • Safety monitoring of drugs receiving pediatric marketing exclusivity
    • Smith PB, Benjamin DK, Murphy MD, Johann-Liang R, et al. Safety monitoring of drugs receiving pediatric marketing exclusivity. Pediatrics 2008; 122: e628-d633.
    • (2008) Pediatrics , vol.122
    • Smith, P.B.1    Benjamin, D.K.2    Murphy, M.D.3    Johann-Liang, R.4
  • 9
    • 34548602369 scopus 로고    scopus 로고
    • Serious adverse drug events reported to the Food and Drug Administration, 1998-2005
    • Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med 2007; 167(16): 1752-1759.
    • (2007) Arch Intern Med , vol.167 , Issue.16 , pp. 1752-1759
    • Moore, T.J.1    Cohen, M.R.2    Furberg, C.D.3
  • 11
    • 61449253058 scopus 로고    scopus 로고
    • Trends in outpatient prescription drug usage in the US 2002-2005 [abstract]. 12th Annual FDA
    • accessed 8 May 2007
    • Worthy KC, Governale LA. Trends in outpatient prescription drug usage in the US 2002-2005 [abstract]. 12th Annual FDA Science Forum 2006; I-13. http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/ search/preview.cfm?keyword=worthy&abstract_id=642&type= coauthor&backto=search (accessed 8 May 2007).
    • (2006) Science Forum
    • Worthy, K.C.1    Governale, L.A.2
  • 12
    • 0034932889 scopus 로고    scopus 로고
    • Gender-based differences in the toxicity of pharmaceuticals - the Food and Drug Administration's perspective
    • Miller MA. Gender-based differences in the toxicity of pharmaceuticals - the Food and Drug Administration's perspective. Int J Toxicol 2001; 20(3): 149-152.
    • (2001) Int J Toxicol , vol.20 , Issue.3 , pp. 149-152
    • Miller, M.A.1
  • 13
    • 61449093881 scopus 로고    scopus 로고
    • Ouellet-Hellstrom R, Kornegay C, Johann-Liang R. Gender-differential drug risk evaluation in adolescents and young adults: examination of top 30 drug prescriptions data. 12th Annual FDA Science Forum 2006; I-PO-28. http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/ search/preview.cfm?keyword=johann&abstract_id= 1016&type=coauthor&backto=search (accessed 8 May 2007).
    • Ouellet-Hellstrom R, Kornegay C, Johann-Liang R. Gender-differential drug risk evaluation in adolescents and young adults: examination of top 30 drug prescriptions data. 12th Annual FDA Science Forum 2006; I-PO-28. http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/ search/preview.cfm?keyword=johann&abstract_id= 1016&type=coauthor&backto=search (accessed 8 May 2007).
  • 14
    • 61449238238 scopus 로고    scopus 로고
    • Designing a Medical Device Surveillance Network
    • FDA Center for Devices and Radiologic Health, Rockville; Sep 1999, accessed 8 May
    • Gardner S, Flack M. Designing a Medical Device Surveillance Network: Report to Congress. FDA Center for Devices and Radiologic Health, Rockville; Sep 1999. http://www.fda.gov/cdrh/postsurv/medsun.html (accessed 8 May 2007).
    • (2007) Report to Congress
    • Gardner, S.1    Flack, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.