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Dr. William Wirshing: State of Alaska's Expert "They are among the most powerful disease modifiers in all of medicine They are a godsend to most people:' Tr.170,Ln.15-21 pip:o~I).I\W_).b] ",_~ ""rirrlo_~.

  1. Dr. William Wirshing: State of Alaska's Expert • "They are among the most powerful disease modifiers in all of medicine •••• They are a godsend to most people:' Tr.170,Ln.15-21

  2. pip:o~I).I\W_).b] ",_~ ""rirrlo_~. (K,~IO,u<l, ~ .~ _ ~ (I._~U O~ "'~ ~~ 't~(_);"""!L 1996 Label- Zyprexa Prescribing Information =. <-, __ ... _....... ' . i' .. iol ='<I' • (~I -. l1oo~~ ('-"""TO" Th<_._I>C,,H .... .s. __ ... -..... _dl"' .... .. cf' ... -""""""" -_ .. ..-. ...... _ • Z'tJ'MX.< _ ... __ "" __ ooIl'. .. (><_, .. 'O .. (" _____ .. ' .""*C .... _ _ ... _ _ _ • or _- .... -.-. ..... - ... No. 2.u-. ~ lJG<»,)'lII'<WI_IljG .. """",1 ~ 1_ ... - ... _ _ , .... _, n _ _ ... _ _ .... """"_ ClJ"'C<L PlUIlMACOLOCY ",.. _ H, (K,ol oM, ."""Ii< ~I ___ ltrr.....,(k.04 ' I olסi._"1. IKo-II-" oM), oM)('f' ,I. __ .. ~~._~ __ _ .. ,. ~I~ _ LIlio:' nIol). _ .<lO<tiMotrl' _. ..... _ Tho ,t ,- .... _ ... _'"",(,..,.>l .nr. ..... .. _ _ ,.""'bo<ol""'l""'4 __ ... ,trr, • __ .o.;lo'o_oI .... _~ .. : ....... _d1-..-.~ d1_ ... __ ... ,. .. """"'d1_"'_"",«fOM'" 01_101 .. __ ,..- - '.....,., = ' ',... i' .. ., .......... -.", -.. .. _......,.61 .•• 1oIIow'ooo;_<nI-.. iI._ '*"'''''''lIrb""" _bolio ... __ ..... _ 0'''' ! .. ' El 2954

  3. -_._-~._._-_ 1996 Zyprexa Label: Weight Gain Information Adverse Reactions: Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials- The most commonly observed adverse events associated with the use of olanzapine (incidence of 5% or greater) _, .. r_ .. __ ..... and not observed at an equivalent _ .. __ ..... _- , ._-_r -----_ .. _ .. 'm ,." incidence among placebo-treated __ n._ t - ,-- patients (olanzapine incidence at least twice that for placebo) were: -' -- - --- - - ••• " Weight gain: olanzapine = 6% placebo = 1 % • (emphasis ildded) , ........

  4. ~ 1996 Zyprexa Label: Weight Gain Information e=- >:'- Adverse Reactions: ••• """--- During long-term continuation therapy --_ "'-----_.- with olanzapine .. .56% of olanzapine ........... _-,,- "' ...... -"._ _ 1',""2 '"" .... _ ..... __ .. _"" ~ --'-"0 •• ..-_ ........ __ .. ,MI" patients met the criterion for having ----"',,---_ ..... ,,-- , . __ -_ .. ,--_ _- __ ,. __ IMl_._ .. __ ,_"_._ _,, .... __ (IWll_. gained greater than 7% of their baseline weight. . __ .. _-~-, --""'-'"----"'''--_ . Dno ... (nI_ ,,_ ...... ..... (emphasis added)

  5. '996 Zyprexa Label: Hyperglycemia and Diabetes Information Other Adverse Events Observed During the Premarkering Evaluation of Olanzapine • Frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing) .... Infrequent adverse events are those occurring in 1/100 to 1/1000 patients ... Endocrine System -Infrequent: diabetes mellitus .. _ • • • Metabolic and Nutritional Disorders- ... Infrequent: ... hypergIycem ia ....

  6. ~ =~ ,~..., -~ '_"_"U_~""" ~·r. A,.~""."" ~~" ~"-., ,~..- --~ ~ _ - ' · I _.~~ ~"'._ ~,_ ~ ~ -~ ~-~ _~.I7l_ -~ ...._-~-<--_ c_~~ Medical Letter: Zyprexa - Body Weight Changes - ""'-'" _._ ... __ . __ .... - ~ . ""'X.I· __ IIOOY .. ,""" ,",_. ........ _ ..... ---..- .. - ------ .. - ..... .. _-_ .. "'---- '- ",-01,,,,_--<,. _ ... _~_, .. ., ... ~,,". ........ _ .. _ .............. _-""""'-.- ...... ")j_ ... - ..... ,." ... " , ............. ,-.-- .... __ .... - .. -- -_ ... _ ........ __ .- ... ...................................... ...... __ .............. ,'.--_.- .... --" .. " .. _,,, ... -...~ _ ..... _>1 _ .. _ .... _ ,_"",...-, • ..,_ --'--"--'--'_._" .. _ .. , .......... ..--.._-- ....... _'-" , .. _- _ ......... AI'<l~ ..... ""' .... _ ... ~_~.-lJ.>J ---_ ..... _ ..... --_ .. -- .... - .... __ .- ... _._---' .......... ..... ..- .................... - ,- w ...... __ .. ____ "" .... ",,;; ........ , ... ,..--._.,,",- .. ---_ . ... ---- -----.- .... _ _" .... ,._"' .. _ . ...... -- ...... --.- .. -_ ... ',,' ... - ........ ---' .... , ..... ,,- -_.- -" ...... _-~ ..... ,,-- ... _._"_.- _ .... , ..... ,_ ....... _ ........ -. ... ~ .... r...... -""'~ ......... _._~ ... -,-- .... _,_ n. •...,. ....... ___ •• """"-""'" -_ ... ,. •• ~,.<.\ ... .' • - .. -.~- "-_ .. -.--.""'---""'-t.:: ... ...-",,, ...... - ..... , ... " '" ~'-"'; !' // ,_.,. ..... ",""""' ... __ .. '" ........ ""' .... _,"""' .... ,"' .... , ... ""'f* __ _. __ .... , ....... _ ... , ,------_ .. ,..-- .............. -_ ... - ""---_.,,,,,--_ .... ... - ....... _, ..... ' -"'E':~ 00.,,,, . ...,.--"...."' ... _._ ........ , I : 1."'-' ,,.,,,, "."'" ~...,.., ,_ •• ~ J _ .. _ ... .--, .. _ ... _. ,,,_ . , - .. -- ,---_ ... ~--- - ..... __ .~ ........ I . " ... --_ ... _--_ .. _ , _ "". - ... ----, ... "._ ........ ,";",.; •• __ .. _" '''''"' .. .... ..- .... 11"] .. "-"'-~'l. "."",----,--..., .. """_'",,,' ._ ...... _ .. - . . . - ... --_." ........... _~ ... _-'"" .... _, ... _ .. ~~ -_._.-._ .... ~.,_ ... _-,~-'." ...... _._ .. - ........ - ... ... __ __ ... " ,-~- ..... _~ .......... _~-,~ .. _ - _. , ... _-- ....... _._-_.,""" ....... ., ....... ....,-'"*', ..... ~-- .... -" "'---,,' ... ,-. .. -..,_ .. ' ... ----,_ .. -... .. ,-_ .. "_I_"-"'''l·'''J, ... "",_~_r ..... _- ........... _ _""0 .. _._-.- ......... -<, ... ,-..._-" .. _ ,--.,,-,< ... ~--- , ........ __ .... ... ~- __ '''''''' .. - ....... - .... ---~"'_._ -. _. ",-_-, ... ____ ...... ... _--_ .... --.-. .. _ .... _._ "_-_"1"'-- __ " "" ...... " ~ ...... c •• _",,,.,,,,,,,-. .. _ • , , ' ......... _~ ..... ____ ... .... ~_."" ..... " ..... _'_'j -"'---"- ..... - .... - .... "''''''''OJ. __ '''''' ." ... "" .. _~_ ..... _--._, ... - ...... ,,,., . _ , ........... _--~_ ......... "'. __ ... ~ ........ ---~--'-~--_. -_ ... ~ .... _._.,- .... wl ...... ,,_._,.,. __ ........... _._ ....... _ ..... ....... ...- Of ____ .... ~ .. -- ....... _ ..... _ .... <".,--- ...... EL 2991

  7. -_.,-~_. -""-~ ~----,-_. ,,~,..'~,,_'-._ ,w~" ~- Medical Letter: Zyprexa - Blood Glucose Changes .. _-_._-_ ... - "'-, ..... _,.-......,-,.,_-.. ,- , --------_ .. .. """" ......... _._--- .. "'''''''''''' o<M,.. .. ... _ - _ - .. _--""- '''''''''''''.-'-<LU:<lSlC>lAl'Gn ..,,,...- .. -- ... - ,- '''' ... __ ,..- ...... .. I _ _-,._ .. _._-_ .. - --'''' --; -." '-"- ... -_ """"' -- .... _,,--_. ---_ ... _---- .. _---_._ ... -- -_-.._ ...... _.- --, -----_ ... _.~ ..... ~ ... -<-I .. _-- """' ... _-_. ..... _ ---_._ .. _""'""'---- _.----_ .... --"..-- V .... ,. L __ _ ..... -_ .. _--_ ... _ .. _ ... .- -_ .. _._-_ .. _-- .- .... -._- ___ "_."' __ ",,_""'..-e_ ....... , '-' __ ,_ .. ""_ .. _ ---<.., ... __ ._---- ..._ .... --- .,., .... _-- ---..-.--_._-+ ' .. ... _ ... _~-... -_._ _..., ..... _~ ... _ _-, .. _---- 0. .... _---_ ..... _ .... ,-- -_ .. __ .... _-,,--- ---- .. -_ .. w. __ _ " -,,---- '"""''--- ._-, .. _ '_oNoo .. _----,-_ . __ .. _- .. '1 ......, •. ",,_ .... _ , .. _ .... "" , .. _ .... - .. _--_ ........ -.....-. ........ ,,,....,.0>11_,, __ \< ...... _ .... _- _ ... __ ._ ....... __ ..... _ .. _"'_ .... .. - .,,,".\ " ..... , ..... _ lJ ............ ". ..... _-_ .. .,.. .. --._- -'-""--=--"'-- _._ .. _ .. _ ''''-'1"'---'''''''' ........ _ .. __ ---- ... --- .. _---_._-_ ... .. _ .... • __ no __ • _ -_ .... _-_ --."- ................ - ... _ -------_ ..... ,-_ .. --,--- ,"" ... ' ... __ _-_ ... -_ .. .. ,------- -_ ....... _---'---- "'-_ .. _ .. "'---_ .. ,-_ .. _---,._,- "--"' ---_ .. -----_ .. _ .... ..-.- .. _ ----- .. .".,-- .... __ ... - .. _ ........ -, .. _--- "" ...... _ . ... ..-.....-_.,..1_ ... __ _ ,1< .. , .. """"- _ tv .." ,., '" .." ' .. EL 2986

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