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Safety and transparency of pediatric drug trials.

Publication ,  Journal Article
Benjamin, DK; Smith, PB; Sun, MJM; Murphy, MD; Avant, D; Mathis, L; Rodriguez, W; Califf, RM; Li, JS
Published in: Arch Pediatr Adolesc Med
December 2009

OBJECTIVES: To quantify the frequency and type of new safety information arising from studies performed under the auspices of the Pediatric Exclusivity Program, to describe the dissemination of these findings in the peer-reviewed literature and compare this with the US Food and Drug Administration (FDA) review, and to describe their effect on pediatric labeling. DESIGN: Cohort study of the 365 trials performed for 153 drugs. SETTING: The Pediatric Exclusivity incentive from December 1997 through September 2007. PARTICIPANTS: Food and Drug Administration publicly available records and peer-reviewed literature retrievable by MEDLINE search. Main Exposures New safety findings obtained from the trials completed for exclusivity. OUTCOME MEASURES: Concordance of the information highlighted in the peer-reviewed article abstracts with the information in the FDA labeling and drug reviews. RESULTS: There were 137 labeling changes; we evaluated 129 of these (the 8 selective serotonin reuptake inhibitors were excluded from review). Thirty-three products (26%) had pediatric safety information added to the labeling. Of these, 12 products had neuropsychiatric safety findings and 21 had other important safety findings. Only 16 of 33 of these trials (48%) were reported in the peer-reviewed literature; however, 7 of 16 focused on findings substantively different from those highlighted in the FDA reviews and labeling changes. CONCLUSIONS: Medication adverse events in children often differ from those in adults, particularly those that are neuropsychiatric in nature. Labeling changes for pediatric use demonstrate that pediatric drug studies provide valuable and unique safety data that can guide the use of these drugs in children. Unfortunately, most of these articles are not published, and almost half of the published articles focus their attention away from the crucial safety data.

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Published In

Arch Pediatr Adolesc Med

DOI

EISSN

1538-3628

Publication Date

December 2009

Volume

163

Issue

12

Start / End Page

1080 / 1086

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Safety
  • Publications
  • Pharmaceutical Preparations
  • Peer Review, Research
  • Pediatrics
  • Pediatrics
  • Humans
  • Drug Labeling
 

Citation

APA
Chicago
ICMJE
MLA
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Benjamin, D. K., Smith, P. B., Sun, M. J. M., Murphy, M. D., Avant, D., Mathis, L., … Li, J. S. (2009). Safety and transparency of pediatric drug trials. Arch Pediatr Adolesc Med, 163(12), 1080–1086. https://doi.org/10.1001/archpediatrics.2009.229
Benjamin, Daniel K., P Brian Smith, M Jessica M. Sun, M Dianne Murphy, Debbie Avant, Lisa Mathis, William Rodriguez, Robert M. Califf, and Jennifer S. Li. “Safety and transparency of pediatric drug trials.Arch Pediatr Adolesc Med 163, no. 12 (December 2009): 1080–86. https://doi.org/10.1001/archpediatrics.2009.229.
Benjamin DK, Smith PB, Sun MJM, Murphy MD, Avant D, Mathis L, et al. Safety and transparency of pediatric drug trials. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1080–6.
Benjamin, Daniel K., et al. “Safety and transparency of pediatric drug trials.Arch Pediatr Adolesc Med, vol. 163, no. 12, Dec. 2009, pp. 1080–86. Pubmed, doi:10.1001/archpediatrics.2009.229.
Benjamin DK, Smith PB, Sun MJM, Murphy MD, Avant D, Mathis L, Rodriguez W, Califf RM, Li JS. Safety and transparency of pediatric drug trials. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1080–1086.

Published In

Arch Pediatr Adolesc Med

DOI

EISSN

1538-3628

Publication Date

December 2009

Volume

163

Issue

12

Start / End Page

1080 / 1086

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Safety
  • Publications
  • Pharmaceutical Preparations
  • Peer Review, Research
  • Pediatrics
  • Pediatrics
  • Humans
  • Drug Labeling