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Email :'iqphvg@;aboo.co{n
Tet:07807820490
2212016 DrugsafetyandAvailability>FDADrugsafetycommunication:FDAreviewfindsrong-term,r"",r""*nn""*,n"".,nrr"0",*rn",-,*
U.S,. Food and Drug
Administration
rrotectins and prom6ting
yo;iij;iii,
FDA Dqlg gafety Gommunication:
review finos long-teirn'ti.eatment FDA
bfood-thinning dedicine pravix with
(cfopidogrel) do; n'ot
change risk of
death
rhis is an update to- the
I5:XtJr
ffnlruo
safetv communicati.,?:IDt
R."views ,-;;r_r;r; nntiprateret
Non-cardiovascurar Death
:f
9r
Safetv Announcement
[11'06'2011.]-4 U's' Food un:
Aotinirtr"'ort
of the blood-thinning orug
review has determined
Pl"ux ?jYs
that
r"roiio"gt"fi
not increas" o,. d".r"ase
overarr risk of
"nnr"r,,,'
orthe ouaiAntiplatelet rherapy death in
qrov
s'e
loner;j
I or death iJq{i:,',.[l.,',il;:1,?[,$ntJ;;ffiiuation
'JtJtttt rlol suggest that clopidogref incre"r",
from cancer.
in"-iisk of cancer
Patients should not stop
taking clopidogrel or other
antiprateret medicines
in an increased.risk
because doing so may
of rt""tt
resuft
orooo
.li"t,
have any questions or
witn
"["trc "ni
care pror"rriJnaf if you
,ra!t
benefits and risks or"'.ilrlr"'""nilp1","t"t
"on"LtnJ"ooutclopJJJgrel. H.""rtn .rrJJ^lr"rrionars shourd consider
the
i""Ji"ir"s before starting treatment.
clopidogref is an antipfatelet
medicine used to
orevelf_brood cfots in patients who
attack' stroke' or probfems
have had a heart
with the
and regs. ri works by hefping
the blood
to keep the
ins tosethe,
crots
::ffiji:,nin
o".r, with cerrain medical
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Resufts from the DAPT
trialwere pubfished
2014' The DAPT-trial comfareiireatment in the New Engrand Journaf of Medicine
in November
witn iuaiantipraiefet tn"ilfv
prasusret
[EffientJ ptus aspiri;t i"; 12
reither cropidogref [pfavix] or
months
placement of a orug-etuting
who had ,ni"rson"
;;;"ry.stent. compareo to patients
;patientswhoweretreateo'witn.iopioog,"rro,io-,ionin,["jl"**i"il,",heartattacksandstent
,!lmg cfopidogrer for montns,
i"rr* qg;il;
^i*ijro
il
heaiattacks-e
I
thrombosisbuthigherr"t""oioJ"rn,
'
:
fn order to investigate
the increased risk of death
and-cancer-rerated death
in the DAPT trial' we
reported with cropidogref
resurts of the onFr
clopidogref with data avaifail;;;'rates
"""tit-"oli"
rong-term crinicartriars
of oeath, 0""*, rrom ."n""r,'lr'i"n."r
reported as an adverse
:
httn.//www frfa nrrvlDrr
ns/Drr rr.Safe.fu/r r:m4712l{i
htm
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