Published online September 1, 2008
PEDIATRICS Vol. 122 No. 3 September 2008, pp. e628-e633 (doi:10.1542/peds.2008-0585)

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services E-mail this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Smith, P. B. Articles by Rodriguez, W. Search for Related Content PubMed PubMed Citation Articles by Smith, P. B. Articles by Rodriguez, W. Related Collections Therapeutics & Toxicology Social Bookmarking                         What's this?

ARTICLE

Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity

P. Brian Smith, MD, MHS^a,b, Daniel K. Benjamin, Jr, MD, PhD, MPH^a,b, M. Dianne Murphy, MD^a, Rosemary Johann-Liang, MD^a, Solomon Iyasu, MD^a, Barbara Gould, BS^a, Robert M. Califf, MD^b, Jennifer S. Li, MD, MHS^a,b and William Rodriguez, MD, PhD^a

^a Food and Drug Administration, Rockville, Maryland
^b Departments of Pediatrics and Medicine and Duke Clinical Research Institute, Duke University, Durham, North Carolina

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.

---

Key Words: pediatric drug safety • Pediatric Advisory Committee • adverse event reporting • drug labeling

Abbreviations: FDA—Food and Drug Administration • AE—adverse event • BPCA—Best Pharmaceuticals for Children Act • PAC—Pediatric Advisory Committee • AERS—Adverse Event Reporting System • SSRI—selective serotonin-reuptake inhibitor • ADHD—attention-deficit/hyperactivity disorder

---

Accepted May 20, 2008.

CiteULike    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				from the Food and Drug Administration's Office of and Pediatric & Maternal Health Staff Pediatric patient safety: the importance of reporting adverse events AAP News, October 1, 2009; 30(10): 21 - 21. [Full Text] [PDF]

				B. A. Noah Just a Spoonful of Sugar: Drug Safety for Pediatric Populations J. Law Med. Ethics, June 1, 2009; 37(2): 280 - 291. [PDF]