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382 Nam Cheong Street'
231,9 8458
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2 September 2011
DH pS PRIE/7-30I15
REPLY PLEASE OUOTE THIS FILE FEEI
Dr, RaYmond LIANG
President
Hong Kong Academy of Medicine
(Fax Numbet:2505 5577)
Dear Dr. LIANG,
to
Food and Drug Administlation (FDA)'1 notifioation
i" th"" drug label for Reclast (zoledronic acid)of
healthcare professionals and patients of an update
*iil i, indicated for the treatment
regarding the risk of kidney faiture. Reclast i;;1";;;
Yoru attention is drawn to the
us
ostEoporosis.
a fatal outcome following Reclast use
cases of acute renal failure requiring dialysis or having
with
tt ot RJdast is contraindicated in patients
havo boen repoded to FDA. ttre revised luU"t "t"t",
;ith evidence of acute renal impairment' fusk
creatinine clearanee less than 35 ml/min ot it p;;;;*
impairment' use of
inolude underlying moderate to severe renat
factors for developine
at the same time as Reclast' or severe
kidney-damaging lnephoioxic) or diuretio medicatiins
Th" risk of developing renal failure in patients
dehydration occprring Uufor" oi after Reolast it
with underlying renafimpairment also incrsases with age'
patients prior to administering Reclast in
FDA advised healthcarro professionals should screen
renal function in
order to idenrifo at-risk patients, Healthcare
iP,:nonitor
,g'R;"tt For details, piease refer to FDA's website:
,;; fuit;
gi;'
;"-frJil"[:l*d-
s/ucm270454.htm
of Aclasta Solution for Infusion 5mg/100ml
In Hong Kong Reclast is registered u4:'-ft" name
prescriptior-onlv medicine' In view of the
(HK-54084) ty Novart senarmac-eutical (H$ ilJ:;Jis a
of tf'u Registation Committee of the
FDA,s action, the issue will be discussed in tn"i".ting
Pbarmacy and Poisons Board.
ovents caused by the drugs-to- the Adverse
Please remind your members to report any adverse
no,: 23lg 86t3, fax: 2147 -0457 or email:
Drug Reaction Monitoring Unit of Department.of ff.aift Col.
websit", rrqy/**r"'psdh.gov,hk at Pharmaceutical
[email protected]). for o"tiifr, ft"*u iufu. tjr tr,"
Serilce rinder';Reporting anAdvene Drug Reaction'
yours siqcerely,
/1 ,
IW
(Ms Pamela LI)
forAD(D)
lTe
are
committed to providing qudity client'oriented sewice
TOTFL P.E1