Abstract: Objective 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. Methods In a retrospective study, to review the 365 trials performed for 153 drugs under the Pediatric Exclusivity incentive from December 1997 through September 2007. To Analysis FDA publicly available records about new safety findings obtained from the trials and peer-reviewed literature retrievable by MEDLINE search, and compare the 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. Conclusion 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.

Key words: Pediatric Exclusivity Program, safety information, labeling changes