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2023.5.20-US FDA panel votes against approval of Intercept fatty liver drug, cites safety issues¡@¬Q¤ÑOCA¦]¬°[¦w¥þ]°ÝÃD³Q§_¤F!
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¤]´N¬O»¡¦pªGNSAIDSÃĪ«¯àªø´Á¥N´ÀAPAP¡A¨º»òAPAP¤]¦³QFDA¤U¥«
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·í¥«³õ[µL]¨x¬rSNP-810¥i¥H¨ú¥N[¦³]¨x¬rAPAP«á¡A
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12.CDER´î¤ÖAPAP¨x¬r¤u§@¤p²Õ¡A¥u¦³1¦ì¤u§@²Õû¤Ï¹ï®ø°£OTC¤¤ªº¹ï¤A酰®ò°ò×ô²Õ¦X²£«~¡C
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2008.02.26
FDAªº«ØÄ³¤z¹w±¹¬I¥H´î¤Ö¹ï¤A酰®ò°ò×ô¨x¬r©Êªºµo¥Í
Janet Woodcock
¡K.Working Group Recommendation (with one dissent): Eliminate acetaminophen from all OTC
combination products.
...FDA·|«ØÄ³±q¥«³õ¤WºM®ø¸ÓÃĪ«¡]¨Ò¦pf¤þ¾JÓi¡^¡Af¤þ¾JÓi»P¹ï¤A酰®ò°ò×ôªº¤£¦P¤§³B¡A¦b©ó¨ä¥L´À¥N²£«~¨S¦³»Pf¤þ¾JÓi¬Û¦Pªº¥X¦å©Ê¤¤··ÀI¡A¤£±N [APAP]°h¥XOTC¥«³õªºì¦]¡A¬O¦bªø´Á¨Ï¥Î¤¤¡A [APAP]¨S¦³ NSAID(ªü´µ¤ÇÆF¡K)ªº¬Y¨Ç·ÀI(G¸z¹D¥X¦åªº·ÀI) ¡C
¤u§@²Õ«ØÄ³¡]¤@¦ì¦¨û²§Ä³¤Ï¹ï¡^¡G®ø°£©Ò¦³OTC¤¤ªº¹ï¤A酰®ò°ò×ô²Õ¦X²£«~¡C
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21»õ¬ü¤¸ªº¿}§¿¯fÃÄRezulin¦]¶Ë¨x³QFDA¤U¥«
www.hantang.com/chinese/ch_Articles/rezulin.htm
www.washingtonpost.com/archive/politics/2000/03/22/controversial-diabetes-drug-is-withdrawn/e4c8103f-b62d-4787-ace9-efa7cb79eb2f /
..FDAªºn¨D¬O¦b½T©w§ó·sªºÃĪ«´£¨Ñ¤F§ó¦w¥þªº´À¥N¤èªk¤§«á´£¥Xªº¡C....Woodcock»¡¡A[¦b¦¹¤§«e]¡ARezulinªº¦n³B³Ó©ó¨ä·ÀI¡C
-------------------------------------------------- ---------------------------------------[¦b¦¹¤§«e]¡ARezulinªº¦n³B³Ó©ó¨ä·ÀI¬O¤°»ò·N«ä?
1997¦~RezulinÀò§å¤W¥«¡A1999¦~»PRezulinÃþ¦üªºÃĪ«Avandia©MActosÀò§å¤W¥«¡A³o2¤äÃĪ«§ó¦w¥þ¥¼Åã¥Ü¥X»PRezulin¦P¼Ëªº¨x¬r©Ê¡C©Ò¥H¦b2000¦~Rezulin³QºM¬[¤U¥«¡C
Janet Woodcock (FDA¥N²z§½ªø)¦a»¡ªk!
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·|û¡GROGER588910148151 µoªí®É¶¡:2021/1/31 ¤U¤È 08:09:40²Ä 649 ½g¦^À³
....2008.02.26
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Janet Woodcock (FDA¥N²z§½ªø)
www.litigationandtrial.com/files/2011/12/2009-4429b1-02-FDA.pdf
¡K¡K§Ṳ́£§Æ±æFDA±Ä¨ú°®¹w±¹¬I¨Ó¸Ñ¨M¹ï¤A酰®ò°ò×ôªº¨x¬r©Ê·ÀI¡A[³Q»~»{¬°]¬ONSAIDSÃÄ(ªü´µ¤ÇÆF) ¤ñ (APAP)§ó¦w¥þ¡C
NSAIDS¡]¤×¨ä¬Oªø´ÁªA¥Î¡^·|¾ÉP«nªºG¸z¹D¯e¯f©MµÇŦ¯e¯f¡C¤z¹w±¹¬Iªº¥Øªº¬O´î¤Ö¹ï¤A酰®ò°ò×ô¬ÛÃöªº¨x¬r©Ê¡A¦Ó¤£¬O [´î¤Ö ] ¹ï¤A酰®ò°ò×ôªº¨Ï¥Î©Î ÅX¨Ï ¤H̨ϥÎNSAID¡C
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·|û:ROGER588910148151µoªí®É¶¡:2022/1/13 ¤U¤È 10:28:07²Ä1587½g¦^À³
¥X²{µL¨x¬rªºSNP-810¡A¦³¨x¬rªºAPAP¸Ó¤£¸Ó±q¥«³õ®ø¥¢?
´£¨Ñ¤@¬q2005¦~ Dr.Woodcock(«ôµn¤W¥ô«áªºFDA¥N²z§½ªø)¦b°ê·|³Æ¸ßªºµª´_ www.govinfo.gov/content/pkg/CHRG-109shrg20047/html/CHRG-109shrg20047.htm
...But in general, in my professional opinion, it is very important to have people involved in decisionmaking who actually treat patients with that condition, because if you
only look at risk we would not have any drugs. It would not be sensible to have any drugs because they all cause harm. Even acetaminophen very common drug, over-the-counter, number one cause of drug-induced liver failure in the United States. If you took that fact in isolation what you would say is that should not be on the market. So you have to have the benefit side right in front of you when you are evaluating the safety problems of drugs.
Á{§É¬ì¾Ç¹êÃÒSNP-810¬O¨x¦w¥þ©Ê°ªªº¤îµhÃÄ--->ªYÄ£¥Ø¼Ð¬OSNP-810¡u¨ú¥N¡v²{¦³¤AñQÓi×ôªº¥«³õ---->¤½¦@°·±d¡G¹ï¤A酰®ò°ò×ô (APAP) ¨x¬r©Ê¡X¡XAPAP ¬O¤£¬O¸Ó®ø¥¢¤F¡H
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.....¥Ñ©ó¥Ø«e¥«³õ¤W©|µLÄvª§ªÌ¡AªYÄ£ªº¥Ø¼Ð¬O´Â¦V¥H°ª¨x¦w¥þ©Êªº¤AñQÓi×ô¡u¨ú¥N¡v²{¦³¤AñQÓi×ôªº¥«³õ¡C¹Î¶¤±N¥Ó½Ð¦w¥þ·sÃij\¥iÃҨô£¨Ñµ¹°ê»Ú¤jÃļt¡A§@¬°±ÂÅv¨Ì¾Ú¡C
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·|û:ROGER588910148151µoªí®É¶¡:2021/9/25 ¤W¤È 10:07:58²Ä1425½g¦^À³
¤½¦@°·±d¡]Public Health¡^¡vªº©w¦ì¨Ó¦ôÈ???
2017. 7.20 William M. Lee
Public Health: Acetaminophen (APAP) Hepatotoxicity¡XIsn¡¦t It Time for APAP to Go Away?
¤½¦@°·±d¡G¹ï¤A酰®ò°ò×ô (APAP) ¨x¬r©Ê¡X¡XAPAP ¬O¤£¬O¸Ó®ø¥¢¤F¡H
www.ncbi.nlm.nih.gov/pmc/articles/PMC5696016/
...¤@ºØ¥þ·sªº¤îµhÃÄ«ç»ò¼Ë¡H
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...§Ú·Q¨ìªº¤@Ó¬Û¦ü¤§³B¬O¤Ú¤ñ§´Ãþ¦w¯vÃÄ¡A¥¦Ì¦b 1960 ¦~¥N©M 70 ¦~¥N«D±`¬y¦æ¡A¦ý¾ÉPµL¼Æ¹L¶q¦º¤`¡C¤@¥¹f¤G´á¨ôÃþÃĪ«¥X²{ ¤Ú¤ñ§´ÃþÃĪ«¥HÅå¤Hªº³t«×®ø¥¢¡C°ÝÃDÅܦ¨¤F¡G½Ö·|¯¸¥X¨ÓÅý¹ï¤A酰®ò°ò×ô¹ê²{³o¤@¥Ø¼Ð¡X¡X¨Ãº¡¨¬³oÓ«D±`¤jªº»Ý¨D¡H
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ã÷®Ø William M. Lee ³o½g¤å:www.journal-of-hepatology.eu/article/S0168-8278(17)32148-7/fulltext (³oºØ·s«¬ÂíµhÃĪº¦^³ø±N¬O¥¨¤jªº!)¥H¯÷ªí´Æg¹|!
¿é:
¥h¬ü°ê©îWilliam M. Leeªº¦ª´Î
R¤j预¨¥¦¨¯u¡A§Æ±æªY辉¤]±o±z预´Á¡A¬Ý¬Ý¦³没¦³10¿Ãn§Q
¦pª¿¨¦³Ð§ë®a´£º¸¡]Peter Thiel¡^¡BGoogle¦@¦P³Ð¿ì¤H¥¬ªL¡]Sergey Brin¡^¡B±F§J®a±Úµ¥¡A»{¬°¤¤°ê¹ï¬ü°ê¥Í§Þ²£·~ºc¦¨¥Í¦s«Â¯Ù¡A¥D±iªGÂ_¥´À»¡C³o¨Ç¤H§ë¸êªº¬ü°ê·s¿³·~ªÌ¡AW©óÃø¥H°l¤W¤¤°ê¥Í§Þ·~¡C
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