???????????????????????(?FDA)
?18??FDA??????????Meeting of the Pediatric Advisory Committee? ?????????????????????????????????????????????????????????????????????????????????1???????????????????????
Meeting of the Pediatric Advisory Committee?2008.11.18?
?http://www.fda.gov/oc/advisory/accalendar/2008/PedMtg111808.html?
?????????????????????????????????????????????????????????????????????????????????????????????????????11????????????Briefing Information????????????????????Slides??FDA?????????????????????????????????????????????????????????????????
??????????????????????????????????????????????off-label????ADHD??????????????????????????????????????
????????2008?2????1?????148??????????????????????38.9???26.3???18?????12????24?????????????????????????????
???????????????????????PARANOID SCHIZOPHRENIA??17.9?????????????18??????????12????20.5??13?17??18.2???????????ADHD?12????18.2??13?17??12.2???????????????
?????????????????1993?12?29???2008?3?28?????????????????????????????????????????????????????????????
| ??? | ??????? | ??? | |
|---|---|---|---|
| ???17???? | 14,910 (10,845) | 14,910 (10,845) | 2,035 (1,272) |
| ???0?16?? | 1,535 (1,183) | 1,207 (860) | 48 (33) |
| ???? | 3,907 | 2,867 | 530 |
| ?? | 20,352 | 15,103 | 2,613 |
??????????????????????????????????????48?????????31??
?????????Serious adverse events???????death?????hospitalization?????????life-threatening event?????disability????????congenital anomaly???
?????????????1?????1671???????????????????????131??????42??????????
?15????????116??????????????????????????????????15???????????Extrapyramidal????????Gynecomastia???????????(Hyperprolactinemia???????????
???????????????????????????????????????????????????????????????????????????11??ADHD???????????off-label?????????????????????????????????????????????????????????????????????????????????????????????????????????????????
???????ADHD????????????????????????????????????????????????????????????????????????????????????????????
???????????????????2008?11?19??