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Safety monitoring of drugs receiving pediatric marketing exclusivity.

Publication ,  Journal Article
Smith, PB; Benjamin, DK; Murphy, MD; Johann-Liang, R; Iyasu, S; Gould, B; Califf, RM; Li, JS; Rodriguez, W
Published in: Pediatrics
September 2008

OBJECTIVES: The Food and Drug Administration Modernization Act provided for an additional 6-month period of marketing exclusivity to companies that perform pediatric drug trials in response to a Food and Drug Administration-issued written request. Because many safety concerns cannot be detected until after the introduction of a product to a larger and more diverse market, the Best Pharmaceuticals for Children Act required the Food and Drug Administration to report to the Pediatric Advisory Committee on adverse events occurring during the 1-year period after granting pediatric exclusivity. We sought to describe the Pediatric Advisory Committee's recommendations made in response to safety reviews informed by data from the Food and Drug Administration Adverse Event Reporting System in 67 drugs granted exclusivity. PATIENTS AND METHODS: Pediatric Advisory Committee meetings and data presented by the Food and Drug Administration for all drugs were reviewed from June 2003 through April 2007. We divided the drugs into 2 groups: those that were returned to routine adverse event monitoring and those that had specific Pediatric Advisory Committee recommendations. RESULTS: Forty-four (65.7%) drugs were returned to routine monitoring for adverse events. The Pediatric Advisory Committee, sometimes working with other advisory committees, recommended label changes for 12 (17.9%) drugs, continued monitoring for 10 (14.9%), production of MedGuides for 9 (13.4%), and an update on label changes resulting from discussions with the sponsor for 1 (1.5%) drug. Some drugs had >1 action. Several of the adverse events revealed during this process were rare and life-threatening. CONCLUSIONS: Safety monitoring during the early postmarketing period is crucial to detect rare, serious, or pediatric-specific adverse events. Fortunately, the majority of drugs given exclusivity had no adverse events of a frequency or severity that prevented a return to routine adverse event monitoring.

Duke Scholars

Published In

Pediatrics

DOI

EISSN

1098-4275

Publication Date

September 2008

Volume

122

Issue

3

Start / End Page

e628 / e633

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Retrospective Studies
  • Pediatrics
  • Humans
  • Drug-Related Side Effects and Adverse Reactions
  • Drug Monitoring
  • Drug Labeling
  • Child
  • Adverse Drug Reaction Reporting Systems
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Smith, P. B., Benjamin, D. K., Murphy, M. D., Johann-Liang, R., Iyasu, S., Gould, B., … Rodriguez, W. (2008). Safety monitoring of drugs receiving pediatric marketing exclusivity. Pediatrics, 122(3), e628–e633. https://doi.org/10.1542/peds.2008-0585
Smith, P Brian, Daniel K. Benjamin, M Dianne Murphy, Rosemary Johann-Liang, Solomon Iyasu, Barbara Gould, Robert M. Califf, Jennifer S. Li, and William Rodriguez. “Safety monitoring of drugs receiving pediatric marketing exclusivity.Pediatrics 122, no. 3 (September 2008): e628–33. https://doi.org/10.1542/peds.2008-0585.
Smith PB, Benjamin DK, Murphy MD, Johann-Liang R, Iyasu S, Gould B, et al. Safety monitoring of drugs receiving pediatric marketing exclusivity. Pediatrics. 2008 Sep;122(3):e628–33.
Smith, P. Brian, et al. “Safety monitoring of drugs receiving pediatric marketing exclusivity.Pediatrics, vol. 122, no. 3, Sept. 2008, pp. e628–33. Pubmed, doi:10.1542/peds.2008-0585.
Smith PB, Benjamin DK, Murphy MD, Johann-Liang R, Iyasu S, Gould B, Califf RM, Li JS, Rodriguez W. Safety monitoring of drugs receiving pediatric marketing exclusivity. Pediatrics. 2008 Sep;122(3):e628–e633.

Published In

Pediatrics

DOI

EISSN

1098-4275

Publication Date

September 2008

Volume

122

Issue

3

Start / End Page

e628 / e633

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Retrospective Studies
  • Pediatrics
  • Humans
  • Drug-Related Side Effects and Adverse Reactions
  • Drug Monitoring
  • Drug Labeling
  • Child
  • Adverse Drug Reaction Reporting Systems