???????2??????????????FDA?
??FDA???12?10-11???????????????????????????????????????????????????????????????????????
Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety & Risk Management Advisory Committee, and the Pediatric Advisory Committee
(December 10 & 11, 2008)
????????????????????????????????????2??????LABAs?long acting beta-2 adrenergic agonists????????????????????????????FDA????????????????????
??http://www.fda.gov/ohrms/dockets/ac/cder08.html#PulmonaryAllergy
??http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-00-index.htm
?FDA???110???60954??????????????????43824???????????????????????????????LABAs??????????????????????????????????????????????????
???????????????460????
Long-Acting Beta-Agonists and Adverse Asthma Events Meta-Analysis??
?PDF?6.53MB?
?????????????2007?11?28????????????????Pediatric Advisory Committee meeting????????????????LABA???????????????Advair? Foradil?Serevent?Symbicort ???????????????
| Brand Name | ???? | ?? | ????? |
|---|---|---|---|
| Advair | ???? | ?????????????? | ???4???? COPD |
| Brovana | ??? | arformoterol | COPD |
| Foradil | ??? | ????????? | ???5???? COPD?5???? |
| Perforomist | ???4???? COPD |
||
| Serevent | ????? | ??????? | ???4???? COPD |
| Symbicort | ??? | ??????????????? | ???12???? |
Summary??????????????????????
- ??????? Foradil?Serevent?Symbicort??????????? Advair??????????
- LABA?????????????ICS?inhaled corticosteroid)???????????????????????????????????
- 4??11???????????????????
- ????????????????????????
- ?????????????????
- 20?????????????16??LABA??????????????????????
??????????????2006??SMART Trial (The Salmeterol Multicenter Asthma Research Trial?????????????????43?????)???????????????????????????????????????????????????????????????LABA???????????????????????????????????????????FDA????????????????????????????????10-11?????????????LABA??????????????????????????????????????????????
???????????????????????????????????????????
?Novartis?(pdf)?AstraZeneca??pdf??Glaxosmithkline??pdf?
????????LABA????????????????????????????
?????
The Salmeterol Multicenter Asthma Research Trial
???Chest 129(1): 15-26?
?http://www.chestjournal.org/cgi/content/abstract/129/1/15
The Safety of Long-Acting ?-Agonists among Patients with Asthma Using Inhaled Corticosteroids
???American Journal of Respiratory and Critical Care Medicine 178: 1009-1016?
?http://ajrccm.atsjournals.org/cgi/content/abstract/178/10/1009
???FDA Documents Say Drugs Increase Risk of Asthma-Related Death
??????Medpage TODAY?2008.12.5?
?http://www.medpagetoday.com/AllergyImmunology/Asthma/12045
12?11??12:00???????
?????1???????????????
FDA Deadlocked on Asthma Drug Risks?ABC NEWS 2008.12.10 AP???
?http://www.abcnews.go.com/Health/ColdandFluNews/wireStory?id=6432289
FDA panel hears risks with asthma drug?Reuter 2008.12.10?
?http://www.reuters.com/article/governmentFilingsNews/idUSN0926618720081211
FDA Advisers Consider Safety of Long-Acting Beta Agonist Inhalers
????Medpage Today 2008.12.10?
?http://www.medpagetoday.com/Pulmonary/Asthma/12117
???????FDA???????????????LABAs?????Foradil?Serevent?????????????????????????Advair?Symbicort??????17?????????????????????????????????????
???????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????
?????????????????????????????????????????????????????????????????????????????????????
???11??????FDA???????????????????????????????
投稿者 by ???????? — 2008年12月11日(木)11:14