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Daniel K. Benjamin Jr, MD, PhD, MPH; P. Brian Smith, MD, MHS; M. Jessica M. Sun, MD; M. Dianne Murphy, MD; Debbie Avant, RPh; Lisa Mathis, MD; William Rodriguez, MD; Robert M. Califf, MD; Jennifer S. Li, MD, MHS

Arch Pediatr Adolesc Med. 2009;163(12):1080-1086.

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.

Author Affiliations: Department of Pediatrics (Drs Benjamin, Smith, Sun, and Li) and the Duke Clinical Research Institute (Drs Benjamin, Smith, Califf, and Li), Duke University, Durham, North Carolina; Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Rockville, Maryland (Drs Smith and Murphy, Rodriguez, and Li, and Ms Avant); Pediatric and Maternal Health Staff in the Office of New Drugs Immediate Office, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (Dr Mathis).

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