;:! Blue Cross of California ‘ @

;:!
@
Blue Cross of California
@ Rob Seidman, Pharm.D., M.P.H.
‘
Vice President
Blue Cross of California Pharmacy
April 30,1999
Food and Drug Administration
Center for Drug Evaluation and Research (HFD
ATTN: Gloria Ortega
5600 Fishers Lane
Rockville, MD 20857
1)
Dear Ms. Ortega:
In suppont of FDA docket number 98P-0610/
P, we have recently obtained copies of
reported adverse drug events for over-the-co
nter non-sedating antihistamines available
in Canada. A search of the entire Canadian
ational database was performed for all
suspected adverse events associated with ov r-the-counter non-sedating antihistamines.
All information provided is current from each rug’s date of initial marketing through April
12, 1999. The Continuing assessment Divisi n of the Bureau of Drug Surveillance in
Canada provided the reports. It is important t note that the reports provided to the
Bureau have not been scientifically or otherwi e verified as to the cause and effect
relationship between the drugs taken and thei potential negative impact on the patient.
\
Of the million of over-the-counter
antihistamine
Canadian Bureau of Drug Surveillance receiv
interaction for fexofenadine, 94 for Ioratadine
these cases where a suspected adverse drug
without any impairment.
In all cases, the rela
adverse event could not be established.
doses dispensed in Canada, the
d 79 potential incidents of a drug
nd 43 for cetirizine. In the majority of
reaction occurred, the patient recovered
ionship between the drug and the reported
1
I
1
In support of docket number 98P-061 O/CP, I quest that the FDA review the over-thecounter safety data compiled by the Canadia
Bureau of Drug Surveillance.
In addition,
please review the safety data in the direct to ver-the-counter
Canadian drug approvals
for loratadine, fexofenadine and cetirizine.
Robert Seidman
cc: Andrea
Masciale
21555 Oxnard Street. Woodland Hills, CA 91367- Tel” (818) 610-4817 Fax: (818) 712-6482
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OUR MISSION To ensure that the drugs, medical devices
and other therapeutic products available in Canada are safe,
PRODUCTS
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NOTRE MISSION: Faire en sorte que les mMic~ents, les
mat%els m&dicauxe~Ies autres produits th6rapeutiques
disponibles au Canada soient slim, cfflcaces et dc hau~e
qualit&
ITS”
THERAPEUTIQUES
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AMME
effective and of high qualiry.
Visit our Website at/ Visitez notre site Internet
www.hc-sc.gc.ca/hpb-dgps/therapeut
CONTINUNG ASSESSMENT DIVISION/ DIVIS1ON DE L’EVALUATION CONTINUE
BUREAU OF DRUG SURVEILLANCE 1 BUREAU DE LA SURVEILLANCE DES MkDICAMENTS
FINANCE BUILDTNG / EDIFICE FmANCE
FIRsT FLOOR / IH ETAGE
OTTAWA (ONTAFUO)
~lA 1B9
ADDRESS LOC#f OR -020 lC1 - INDICE DE L’ADRESSE
FAX: (613) 957-0335
a
TOIA:
Robert
FAX: 1 [818) 712-6482
TEL: (81 8) 610-4817
DATE: April 13, 1999
Seidman
NUMBEROF PAGESTO FOLLOW:61
NOMBREDE PAGESA SUWREL
MIZSSAGEMESSAGE:
Dear Mr. seidman,
This is further
information
on suspected
fexofenadine
cetirizine,
1998 requesting
to your fax dated December 16,
adverse drug reactions
(ADRs) associated with
and loracadine.
We apologize for the delay.
the use
of
A search
of the national database was performed for all the suspecced
adverse reactions
associated
with these suspected drugs. The attached printouts
since
marketing
unc il
cover the time period
outline the results . These printouts
There may be reports
which have been received by che program.
12, 1999.
April
direcc
your attention
of all
which are not yet
entered into the database. Kindly
Caveat:
persons
using
these
printouts
to the following
CAVRAT : The vast
majority
of report= on which this summary is based
are
submi~ted
by health practitioners
and to a lesser extent laypersons.
Each report
opinion or observat~on of the individual reporter.
represcmts
the suspicion,
in the vast
majority
of
Cause and effect relationships
have riot been established
The information
contained in these reports to the Health
reports submitted.
Protection
Branch is raw information
and has not been scientifically
or othe=ise
and effect
relationship
by Health Protection Branch
verified
as to cause
Only a small proportion
of suspected adverse reactions are reported
scientists.
to the program,
consequently
this information
must not be used to est%mate the
incidence
of adverse reactions.
Re:ports submitted by pharmaceutical
This summary contains unpublished
manufacturers
are included in this summary.
data and is provided
to you with the understanding
chat this data will be used
only within your immediate organization.
If you
have
any
further
questions,
please
PaScale
RECEIVED
TIME
RPR. 13.
11:51RM
do not hesitate
Springuel
to contac~
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RPR
13
Heal&
Canada
’99
14:41
FR
B DRUG SURUEILLRNCE
Sant&
IULb
Canada
A
613
957 Et335 TO
‘Y4
z:
~P&We
Zr:
VA-
~:
#
PROGRAMME
P
b~
OES
D
RO
U
1
NOTRE~SSION:
Faire ensoneque Iesm+dicamenw, les
rnah%ielsm&licaux et lessums produhsKh&apeuti~ues
1S
THERAPEUTIQUES
~
[;.,
disponibles au Canada soient SIMS,efflcaces et de haute
qualitfi. ~.
TH~RAPEUTIC
PRODUCTS
*
PRo
;)
OUR MISSION. To ensure that the drugs, medical devices
and other therapeutic products available in Canada are safe,
effective and of high qualky,
GR AMME
,.;
Visit our Website at/ Visitez notre site Internet
www.hc-sc.gc.ca/hpb-dgps/therapeut
.:
,
,.
;,
,.
.,
,,,.~
CONTINUING ASSESSMENT DIVISION / DIVISION DE L’EVA,LUATION CO~
BUREAU OF DRUG SURVEILLANCE/ BUREAU DE LA SURVEILLANCE DES MEDICAMENTS
FINANCE BUILDING / EDIFICE Fl_NANCE
FrRST FLOOR/ 1= ETAGE
~,
,,.
<.:
OTTAWA (ONTARIO)
!
KIA IB9
ADDRESS LOCATOR -0201C1 - INDICE DE L’ADRESSE
FAX: (613) 957-033S
:.
,
;j
ToIA:
Robeti
FAX: 1(818) 712-6482
TEL: (818) 610-4817
Seidman
DATE:
April
13,
1999
.:.
NUMBEROF PAGES TO FOLLOW:61
NOMBRE DE PAGES~ SurVRE:
MESSAGE/MESSAGE:
Dear Mr, Seidman,
This is further
information
on suspected
cetirizine,
fexofenadine
.:
to your fax dated December
16, 1998 requesting
adverse drug reactions
(ADRs) associated
with
We apologize
for the delay.
and loracadine.
the use
of
A search of che national database was performed
for all che suspected
adverse reactions associated
with these suspected
drugs. The attached printouts
These printouts
cover the rime period since marketing
until
outline the results.
There
may be reports which have been received by the program
April
12,
1999.
Kindly direct your attention
of all
which are not yet entered
into
the database.
persons using these printouts
to che following Caveat:
CAWAT : The vase majority of reports on which this sumnary is based are
Each report
submitted by health practitioners
and to a lesser extent laypersons.
observation
of the individual
reporter.
opinion
or
represents
the suspicion,
been established
in the vast majority OE
Cause
and
effect
relationships
have not
The information
contained
in these
reports
to the Haalkh
reports submitted.
Protection
Branch is raw information
and has not been scientifically
or otherwise
as
to cause
and effect relationship
by Healti
Protection
Branch
verified
scientists.
Only
a small
proportion
of suspected
adverse
reactions
are reported
the
to the program, consequently
this information must not be used to esrimate
incidence of adverse
reactions.
Reports 6&mitted
by pharmaceutical
manufacturers
are included in this sununary. This summary contains unpublished
data
and is provided
to
you with the understanding
that this data
will
be used
only
within
If
your
you
immed%ate
have
organi,zati.on.
any further
questions,
please
do not
hesitate
to
contact
.:
:.
‘$
,,
.;.
~
me,
‘,
Pascale
RECEIVED
TIME
RPR, 13.
11: 42RM
Springuel
w.
Canadian Adverse Dmg Reaction ,Monhoring Program
Summary of Re orted Adverse Drug Reactions
Active Ingredient: L orrshdine - “Inte?rssclion - Food”
AN Reports received and en(ered into dsl(stbnscbefore April 12,1999
Case report
ntsmber
Drug
Agc
Sex
Mnrne
Dosage
Duration
of
treatment
Drug
Involvement
.
Dose of d rug
D
w
m
Outcome
form
R
rcmfik
80088173
2
r-l
u
•1
!-l
?
NoI w ~ecwiwed
01 Day(s)
CLARITIN
System L&m
lntertic(ion -Food
WHO
CkIsK
CENTR & PERIPH NERVOUS SYSTEM DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
Orgm
I Daily
Reaction Term;
COMA
ANAPHYLACTIC
FOOD REACTIONS
$Wettt
Adverse
10.()() Milligrms
REACTION
lnferwc[ion -Food
WHO Adverse
Class:
CENTR & PERIPH NERVOUS SYSTEM DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
Reaction
COMA
ANAPHYLACTIC
..
m
u
m
c
m
Term:
REACTION
Told No. of repot-h
,. .
Total IVoi of reporfs withftrtd “otitcbhte
55
1
‘$
F
r
D
z
n
m
m
G
-o
b
N
.
CAVEAT
The vasl majority ~freporls on which this sommrnry is basedamsubmilkdby hcal{h pracfjtioners and [o a lesstr extent laypwsxxss. lkh ru ort rcpreserststhe wsspicion,
majority ofrepor[s submitted. T f?”
e reformation eon[;]ined in these
opinion or observation of the mdividurd repwter. Cauao and efkm ruia[iorashipshave not been estsbhskd in lhsVZR4
rqmrts to the Ffesd4hCanada is raw uaforma!ion and has not been scicmiflca!ly or otherwise verified as (o ease and effed relationship by I+e+dth Canada .scien~ists,Only a small
orliw of su ectcd adwme resetions am reported to the pro mm, consequent y this in fom:ation must not be used to eshak USCincidence of advew reac[ions. Re ods submh[ed
{~~amw~lic%rnat\uiactu:et:m
included in ttis~mmar ~ ~is..nwrmry
containsullpublishedd,~md
isprcwidedto youwirh sheunderstandirrg thal thisdataw~ berswd only
Unk,Burcms..o.fDrug .Survcillanw, Tltcmpct]tic F?rodrsctsProgrammc.
.
,.~wi so ymrr.~~rnedlateorgarrrzaftoo. Produced &y; -Adverse FMgReaatirmReportkrg
h
IS
April 12, 1999
. .
Page !.ofl -
Adverse
Drug
Rs=action
Monitoring
orted
Aciv=rs=
Drug
React
Summary
of Re
““Interaction
K orata
dine
as
Active
Inz?redit?nt:
R=Por*s
r=ccs5v-eci
and
entered
into
database
before
Canadian
All
Dosafge
fo a-m
Duration
of
treatment
Drug
Program
iot~s
drug”
Aprfi12, 1999
Involvement
Outcome
Dose of drug
1
Recovered without seqsrelnc
03
Day(s)
Irstaracdon-Drug
10.00 MiRigfams
I Daily
b
WHO Adverse Reaction Term;
SYSTEM
.JS
MIGRAINE
DISORDERS
Ckntinuin=
on
Drug
Concomitsd
1.00 Dosage form i Daily
Recovered widr scquclse
Xnter*cllon
,AR
DISORDERS
:ERAL
DISORDERS
(AR
DISORDERS
-Drug
1.00Dosage form I
TNNITUS
1,00Dosage form 2 Daily
WHO Adverse Reaction
DISORDERS
~lSORDERS
DISORDERS
DISORDERS
DISORDERS
DISORDERS
DISORDERS
DISORDERS
DISORDERS
y
WHO Adverse Reaction Term:
HEARING IMPAIRED
CONDITION AGGRAVATED
Imteradioll. -Drug
‘ERAL
:ERAL
(AR
:ERAL
IAR
(AR
(AR
/AR
1A R
D4il
-,.=
Term:
CONDITION AGGRAVATED
CONDITION
AGGRAVATED
TINFUTIJS
CONDITION AGGRAVATED
TINNITUS
HEARING IMPAIRED
TINNITUS
HEARING IMPAIRED
REARING IMPAIRED
1 n Cc ra c rion -Drug
DISORDERS
IERAL
DISORDERS
AR
DISORDERS
AR
DISORDERS
AR
DXSORDERS
AR
DISORDERS
EML
WHO Adverse Reac!ion Term:
CONDITION AGGRAVATED
CONDITION AGGRAVATED
W3ARING IMPAIRED
HEARING IMPAIRED
TINNITUS
TINNITUS
.
N
su bm itted
by
hea
ILh
p rztctit
ionc~s
and
to a tcsser .extem t laypcrwns. .Eoch !eporl r,epmysts \hc suspicion,
m
ips have
not
been
established
us thss vast m ajorlty
of reports wbrrmcd. The inhrrnatton etmtaincd in ihese
ft-ect
relations
April 12, 1999
en scienti~lcally
or otl~erwise
verit3=d
as to cause
and
c=ff=ct
rclatioxlshlp
by I-lcalthCanada scifmtish Only a small
consequ
=ntl y this information
n rrsust
not
be us=d
to estisn at= theincidence of adverse ferwlions. Re rrds submi!!ed
‘“%%%krrsn.ary
contains
unpublisi,ed
data
arsd
is provided
*O you
WA tievl,dcrs,anding (k,,l]isda{a!vfi
beusedoniy
Page 1 of4
~oducts
Program me. . ,L. ,.,...- .-+< ,. ,..,.,
brug
Rez~c~iosT
,Reportirxg
.Un it, ~.uqeau
,,of J2ru~
Survc=il
Jane=,... Th,erap,eutic,
-,:.
.
,,......‘,,.-....-,,.
,;.. :,:., ~!.... ...;-,; .+Y .<----... .
., :..,
v
is based
IISzl
B
ssre
25
~I=ARITIN
Year(s)
Female
d
$1
Organ
CIass!&
PEIUPI-3
NERVOUS
SySterr;
CENT’R
5
OVRAL
49
0S06S9
D
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w
sex
A~e
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name
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report
number
q%
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i-i
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u
+
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tern
Sys
HEAILIhTG
130DY
l+CEAJllNC5
SELDANIZ
S2yst=m
BODY
130DY
HEAIU_NG
BODY
HEARTNG
HEARING
HEARTNG
HEARING
HEAIZING
TAG
AME~
Y car(s)
Female
C! LA
ii
I-u
2
*sfem
Organ
AS
CZass:
AND
VESTI’J3ULAR
A
VVI-IOT-E
- GEN=R
AND
VESTIBULAI<
Organ
CZuss:
AS
A
WHOLE
- GENERJ
AS
A
VVHOLE
- CiENERJ
AND
VESTI13ULAR
AS
A
~OLE
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AND
VESTI13ULAR
AND
VESTI13ULAR
AND
VESTI13ULAR
AND
VESTH3ULAR
AND
VESTXBULAR
Orgum
Clu.ss:
AS
A
WHOLE
- GENERJ
AS
A
lVHOLE
- GENERJ
AND
VESTI13ULAR
AND
VEST113ULAR
AND
VESTIBULAR
AND
VEST113ULAR
E30DY
BODY
HEARING
HEA~C3
HEARING
HEARING
L
‘A-AT:
pinion
or
>ports
to
roportion
The
vast
observation
~~in
your
of
reports
react
T manufacturers
imrn=diate
011 which
reporter.
individual
is raw
in forma
t.h= Health
Canada
adverse
ofsus
e~teci
harrnaccutica
.. .
majority
of the
.orga:~iza*io.n-.
i-ens
are
t$oll
are
lncludcd
..
Produced
,..
.
this
su~mmary
and
Cause
and
has
repor[ed
in this
,~y:
not
to [he
summar
, Adv~.rse...
is
effecl
bc=n
I
S(
r
pro
&
%
rug
El
Canadian AdverseDrug ReactionM onikwing Program
Summary of Re )oned AdverseDrug Reactions
Active l“grcdicr)t:~oratadincas
“ln(esvscthssdrtsg”
before April 1211999
All Reports received and entered into dsstabssss!
D
Case report
number
R
~
H
<
Age
Sex
70 Yeur(s)
Fesnuk
Drag
name
oofi4173
Dosage
form
Duration
Sy{em
II
D
Irnterac!ion -Drug
P
i-. .
b.
N
D
3
Milligcams
~
Terns:
7
m
w
w
m
c
3.00 Gmsns
WHO Adverse Reaction Texm:
TACHYCARDIA ATRIAL
HEART RATE AND RHYTHM DISORDERS
CARDIOVASCULAR DISORDERS, GENERAL
HEART RATE AND RHYTHM DISORDERS
COUMADIN
LANOXIN
LASIX
w
10.00
‘%
TACI+YCARDIA VENTRICULAR
System Orgcm Class:
1-
Outcome
Dose of drug
ECG ABNORMAL SPECIFIC
TACHYCARDIA ATRIAL
GRAVOL
-0
aJ
Drug Involvement
WHO Adverse t?eaclion
Organ Cktss:
CARDIOVASCULAR DJSORDERS, GENERAL
HEART RATE AND RHYTHM DISORDERS
HEART RATE AND RHYTHM DISORDERS
-1
H
3
treatment
Interaction -Drug
CLARITIN
II
u
of
c1
ECG ABNORMAL SPECIFIC
TACHYCARDIA VENTRICULAR
Milligwrrrs
Concsssnilanl
2.50
Coricosnitant
0.25 Miiligranw
Concomilfiot
20.00 MiHigrams
D
z
r-)
0084437
20 Yci+r(s}
06 DiI)q(S)
CECLOR
system
m
Female
[okra Non -Drng
7S0.0 Milligrams
WHO Arherse Reaciion Term;
Organ Class:
HEARr RATE AND RHYTHM DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
PALPITATION
BODY AS A Wf-10LE - GENERAL DISORDERS
SYNCOPE
TACHYCARDIA
(n
ul
4
CHEST PAIN
HEART RATE AND RHYTHM DISORDERS
CLARITIN
I Driily
10 Day(s)
ln~eracflon -DrIsg
10,00 Milligrams
System Organ Chrss:
WHO Adverse Reaction Term:
BODY AS A WHOLE - GENERAL DISORDERS
HEART RATE AND RHYTHM DJSORDERS
HEART RATE AND RHYTHM DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
PALPITATION
TACHYCARDIA
SYNCOPE
m
LAJ
cd
(n
1 Daily
+
o
CHEST PAIN
1-
4
-0
k&
\
ru
Kl
!-
CAVEAT: The vu majority of’ rcpwfs on which this summary is based nrc submkd by heallh praclilionefs smdto a ie~er-axkq{ laypersons. .Ea~I re Orl reprew+ts (he w,spicion,
reporter. Cars=andcffed relahsships have no( been established in the vas4rnajoruy of rcpsm submrued. “1”
r ~ Ipfor.mal!onconlamed in lhcse
opiniossor observation of Ihe issdividual
reports to the Heallh Csmada is raw information and has noI been scien[ilkally or odserwise verified as to cause and effi! relationship by Iicidrh Canada SVICI}IISt+ Onl a small
roportion of WSSccfed advcrsa rctscl!onsam mporied to Ihe pr mm, consequently this issforutationrnusl no[ be srsedw eslimale fhe incikrsce Of advef= stacpss. ~ or,susbnsi[[rxi
dala and isprcsvided IO you with Utetsndws{mrdmg thal flnsdata wfi be used only
. arnsaocuhca manrr[aclu{e(s are included m lhis surnnsas ,’%issussunsrry con(ail)sunpubltiid
“$lyourinlrn~i~[~
organhalion, Produced by: Advwse kg. Reacdon Repor[i”g Unil,
\vl
Bw-tw of Dru~ Surveillance, Thcrapeu[icProducK Programme
April
..
12,
1999
Page 2 of4
Canadian Adverse Drug Reaction Monitoring Prwgram
Summasv of ReDosled AdverseDrw Reactions
Aclive Ingr&licnt:
All Reports reccivcd and
Case report
number
Drug
mime
:m
Irl
;~0086653
l-l
Sex
Age
3Y ehr(s)
PSYCHIATRIC
H
3
Duration of trealmcnl
DISORDERS
PSYCHIATRIC DISORDERS
23 D&)’(S)
INTAL
D
30 Y rar(s)
3 (J087094
w
b-l
Dose
lsskraction .Drug
of drug
S.00 Milligrmus
Oukxme
1 Daily
organ Cltlss:
CENTR & PERIPH NERVOUS SYSTEM DISORDJIRS
RESPIRATORY SYSTEM DJSORDERS
BODY AS A WHOLE - GENERAL DISORDERS
MUSCULO-SKELETAL SYSTEM DISORDERS
06 Day(s)
MINOCJN
$rsftvn Orgun Claw:
MUSCULO-SKELETAL SYSTEM DISORDERS
CENTR & PERJPH NERVOUS SYSTEM DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
RESPIRATORY SYSTEM DISORDERS
Concfsmitnnt
3.00 Dosage form 3 Daily
Recoveredwithout sequclac
10.00 Milligrams
WHO Adverse Reaclion Tern):
CRAMPS LEGS
DYSPNOEA
FATIGUE
ARTHRALGIA
1S0.0
Intcrsivlism -Drug
Milli~rams
WHO Adverse Reacfion Term:
ARTHRALGIA
CRAMPS LEGS
FATIGUE
DYSPNOEA
Rmcswred
ki~how~scquclac
Fclndc
0087319
CLARITIN
EXTRA
Sy.slem Organ Class:
CENTR & PERIPH NERVOUS SYSTEM DISORDERS
MA NER]X
SySfem Organ Class:
CENTR & PERIP1I NERVOUS SYSTEM DISORDERS
CLARITIN
j
SLEEP DISORDER
HYPERKINESIA
EMOTIONAL LABILITY
lnf crac[ion -Drug
,S)Is(enl
w
:
l-v
D
3
Drug Involvement
l%MISIG
CLARITCN
w
12,1999
WHO Adverse Reaction Term:
class:
CENTR & PERJPH NERVOUS SYSTEM DISORDERS
r-l
drug”
Reuovemd with seqrrelae
03 Wck(s)
$wlel?) organ
as “Inkrac(ion
Female
CLARITIN
‘6
o
+
Dosrrge
form
~ortikdinc
entered into dalabsssebefore April
Intwssc(iou -Drug
2.00 Dosage form
WHO Adverse Reac[ion Term:
MYOCLONUS
Intcracfion
-Drug
300.0 Milligrams
2
Daily
WHO Atfvesxe Reuction Term:
MYOCLONUS
Other
As nwxary
CAVEAT:The vast swjorily of rcpofls ou wfsich this summary is bawd we suhmiwl byIMMMIpractitioners and to a lesserwknt Iaypersons. J%h report rqsrcscols the suspicion.
opinion or obaervn[ion of [h! rstdiv@tlhrsl
reporkr. Cmsscwd effect relatiowhips hrwe uot been esudtlishcd k Use VSM mnjori(yof rcpods submitted. The information containsxi in Ihcse
scicnlis!$, Onl a snsall
reports m !JseHealth Canada IS raw m!ormatiow and has not been seienlitlcally OFolhelwi.% vcrifred usto cii~~ and clket reltstionsh!pby lkallh Cassisdts
o orfion ot”sus cckd ssdvcw rcwksosssarc rcporled m k pro ram, eonsquen(ly t))is intiunnution mud not be ssscdto eslirsmk Ihe hwidcnct of adverse wauhorw J/” ortssubmit[esi
&#arn,acet,lim!
n)anuf*c[urcrs arc included in this msssntar~ %hissummmy con,{,,nsu,]publisl,cd rkdannrlisptovided 10you with the understanding hiihisdsrm wfibe u=donly
..
ws in your irnmedia(c orgao izolioo. Reduced by: Advwse rug IkacliaN Repor!iwg Uoil, LlureauofDrug Suwelllanw, Therapculic ProdsscrsProgfamnw
April 12, 1999
Page 3 ofd
Adverse DsucReaclionMonitoring
Program
Summary of Re o~ed Adverse DNK Rcaitioni
Acfive Ingrcdicl,t:torafadine
as’’ln(eraction drug”
All Reports receiycd and entered into da{abfrse before April 12,1999
Canadian
Case report
number
m
i~ 0087961
ii
F
(U
.+
Age
Drug
name
sex
Dosage
Duration of treatment
Irl
‘D
-o
?0118S05
P
cd
W
Male
a
Continuing on Drug
CLARITIN
THERAPEUTIC
WHO Adverse Reuction Ternl:
46 Year(s)
EFFECT
lntmredon -Drug
I Dossge form 2 Daily
HEMORRHAGIC
lnlerrrcliurr -Drug
WHO
Class:
& CLOTTING DISORDERS
Continuing on Drug
~dvet-.se
DISORDER
7 Wfigrams
Dmily
Reaclion Terns:
HAEMORRHAGIC DISORDER
Coucon]lWst
1 IXssagc form I Daily
Werflction -Drug
I Dosage form 2 Disily
Mine
EXTRA
2 Daly(s)
WHO Adverse Reaction l’crn;.-
system Orgon Chss:
SKIN AND APPENDAGES DISORDERS
COUMADIN
RASH HEMORRHAGIC
condnuirrg on Dwg
[rrferacfion -Drug
5 Milligrrsms I Daily
WHO Adverse Reac!ion Term:
Sptem Organ Class:
RASH HAEMORRHAGIC
SKIN AND APPENDAGES DISORDERS
ASPHUN CHILDRENS
m
w
aJ
c
c1
WHO Adverse Reaction Term:
Organ Class:
45 Ycar(s)
CLARITIN
THERAPEUTIC
Unknown
2 Day(s)
PLATELET,BLEEDING
ASPIRIN CH[LDRWW
0119061
Lo
EFFECT
Male
EXTRA
Organ
i
q
In!erae[ion -Burg
UNEXPECTED
System
D
3
UNEXPECTED
BODY AS A WHOLE - GENERAL DISORDERS
PLATELET, BLEEDING & CLOTTING DISORDERS
Coulimring on Drug
COUMADIN
IR
10.00 Miltigrrrms
S).rlem Organ Class:
$Istwn
+..
Ivttrnc(ion -Drug
WHO Adve]se Reaction Term:
Syslem Organ Class:
CLARITI.N
F
D
-u
m
1-
Outcome
Dose of drug
form
BODY AS A WHOLE . GENERAL DISORDERS
(%nlirruing on Drug
PROZAC
IH
:x
Drug Involvemeuf
(lrsrtinuing on Drug
Corrconlila nf
I Dosage form I Daily
Total No. of reports
Told No. of reporh with fkl
N
outcome
-0
b
o-l
&
vas!
rnajorhy of’ rcpolts on which dlis summary is brsscrlw srrbmillwl by health practitioners rrrsdw a Iesscr exkmt Iaypersons. EtIch re orl repwsemtsOICsuspicion,
CAVEAT: TJIC
1 e mformalion
.
contained in these
ophtiou or obswvariion of die individua I reporlcr. Cause and effect relationships have not been cstabiishcd in Ote VS.Mmiijorily of reports submitted. “’{
repmis to the Heal[l\ Canada is raw inform alien and has not been scitxrti!ically or otherwise verified its[o cass~ and elk! reladon$hip by Health Carsridascierrlisb. CM a small
y this inform a!ior! must no! be used lo estimate he incidence of stdveraareaclions. ~ ortss.bmi~ted
m orfion ofs.~c!ed
adverse rixrcdons ar. reporfed to{hepm r~m, cosiseqsrerrtl
unpublkl)ed data and ispovided io you widr the undcrsmding!ba[ lhisdatn ~ifibc used only
ly}haunaceulica
rnanufaclurers are irscltrdtxiin lhis.smrrsrrrrf, $l]issl}n]nla~~ntains
.
. .
WI Jsayour imrrlcdiisle.organizrs!ion.. Prrdueed by: Adverse &rgRetw[ion Ikporting Wri,, Bure,w of DrwgSwweillsmec. ThcraPeuticProductsl’rograntnlc.
J1
K1
April 12, 1999
Page 4 of4
Canaciiars
Aciversa
Summa~A~~i~g
All
received
ReFsorts
and
Drug
Reaction
Monitoring
ox-ted
Adverse
Drug
Reactions
% nggreclient:
Cetirizlne
entered
into
clatabase
before
Dws-ation
Dosage
form
of
treatment
Drug
Program
April 12,1999
Dose of drug
Involvement
Outcome
10.00 Milligrams
S us peckd
WHO Adverse Reaction
ABNORMAL
WISION
f
Term:
Rwovwed wilhoul sequelse
Sus~cctcd
10.00
Milligrams
WHO
:S
SYSTEM
Adverse
Reaction Tertn:
TARAESTHESIA
IIROWSJNESS
DISOR-DERS
Concomimnt
500.0 Milliglnms
Concamitanl
--
Conszamifnnt
10.00 Milligrmns
Sus~ccted
WHO Adverse
Reaction Term
SOMNOLIWCE
Con
c omkrn!
S us g~eefed
!0,00 MiUigrams
WHO Adverse Reaction
Swspecled
10.00 h’lilligmms
WHO Adverse Reaction Tew:
THROM130CYT0PElWA
DISO-ERS
LOTTING
Term:
l%lYALGIA
I’vIUSCLESTIFFNESS
‘TEM
DISORDERS
S SYSTEM
DISORDERS
S us pccfed
WHO Adverse Rewfion
S
SYSTEM
Term:
CONVULSIONS
DISORDF.RS
!aypwons. ,Ewh rcpo!t represryts ihc suspicion,
is based
are su bm itted b y health
practitioners
and
to a lesser
-extent
FCect relratioliships
have
not
been
establ
ishcd
in tl~c vast
m ajorxcy
o f repW$ submmcd. The mfosyswn contained in those
en scientiticalX
y or otherwise
veritled
as to cause
and
effect
relation
shtp by Heallh Canada scienwds. Ord a small
consequs=ntl
y this
in formation
m ust not
be used
to estisn ate USCimcidence of adverse reactionk ~e W-ISsubmitted
j“%%%k.ssnrnary
lrujg:*acC-ion:,
H
1333
corstains
Xporti.ng..
unpublished
Uni G Bureau
data
and
is provickd
of =rsr~
.Survc3i
Ilance.
to
YOU
with ticundcrdmdtig(h
Therapeutic
ProducIs Programnw.
~thkddow%beused.nly
April
12, 1999
Page lof14
.
Case
report
number
-Female
Year<s)
42
;~7Sc5Z9
H
<
II
o
+
-3’
sex
Age
Drug
naxne
REACTINE
1!
organ
.%=
fern
VISION
M137ss25
class
;“
DISOIUDERS
43
Female
Year<s)
REACTIFJE
D
-u
m
.
‘+
.w
P
P
ii
ALLBEE
Sysfem
Organ
Class:
CENTR
&
PERI
I?H
NERVOUS
J?SYC151ATRIC
DISORDERS
WITH
C
ALLERGY
TYLENOL
:
IPJJECTIION
—
0s1394
Male
REACY171NE
SY.S fern
Orgam
Class:
MUSCULO-SKELETALCENTR
&
PERIPH
4
086041
Year(s)
SYSTE
NERVOUS
S
Female
REACTINE
System
PLATELET.
25
386042
0rgcz72
Class:
Y3LEEDIFTG
YearCs)
&
CI-0”
Male
REACT1N13
Sysf=n7
CENTR
Organ
&
Class:
I? ERIPH
NERVOUS
5
El
Canadian
Adverse
Drug Reaction
Monitoring
Program
Summary of Reported
Adverse Dru$ Reactions
Cetirizmc
Active Ingredient:
All Reports received and entered into databrssebefore April 12,1999
Ctise report
X
II
~
..
H
<
r-l
u
number
Sex
Age
Drug
name
0086043
-—.——
53 Yea((s)
Dosrrge
form
Durdion of treatment
-i
Organ
Class:
PROVERA
34 Y cac(s)
~ 0086300
5.00 .Milligrams
!
WITHDRAWAL SYNDROME
WITHDRAWAL HEADACHE
Concomitarvt
Female
Recovered without sequclac
Snspectwl
REACTINE
v
U
Suspected
(htcorne
WHO Adverse Rcwction Term
BODY AS A WHOLE - GENERAL DISORDERS
CENTR & PER[PH NERVOUS SYSTEM DISORDERS
2
l-l
Dose of drug
Fcnmk
REACTINE
$@m
Drug Involvement
10.00 Milligrams
.
Sysfem Organ Clr.w,w
WHO Adverse Reaction Term;
+
w
..
GASTRO-INTESTINAL SYSTEM DISORDERS
BODY AS A WHOLE - GENER4L DISORDERS
GASTRO-INTESTINAL SYSTEM DISORDERS
NAUSEA
WITHDRAWAL
k
g
RESPIRATORY SYSTEM DISORDERS
SYNDROME
VOMITING
SPUTUM INCREASED
Wmulc
0086454
Rewwred wilhont scquelae
Suspected
REACTINE
10.00
Milligrams 2 Daily
Sy.wm Organ CIas.s:
WHO Adverse Reaction Term:
SKIN AND APPENDAGES DISORDERS
GASTRO-INTESTINAL
SYSTEM DISORDERS
DISORDERS
SKfN AND APPENDAGES
BODY AS A WHOLE - GENERAL DISORDERS
HEART RATE AND RHYTHM DISORDERS
SWEATING INCREASED
FAECAL ABNORMALITY
NOS
SKIN COLD CLAMMY
MIGRAINE AGGRAVATED
CHEST PAIN
ARRHYTHMIA
PSYCHIATRIC DISORDERS
ANXIETY
CENTR & PERIPH NERVOUS SYSTEM DISORDERS
19YCiV(S)
0086660
Female
system Organ
Rwovemd without sequclae
Suspcctecl
REACTINE
Cluss:
SKIN AND APPENDAGES DISORDERS
10.00 Milligrams
1 Daily
WHO Adverse Reactio~z Ternl:
URTICARIA
.
CAVEAT
llc vau n]ajori{y c~freports on which this summary is basedye s~bnlit[ed by heaklr pmc!,hione!s and (o B leSW,eXWIt Iaypmons. ,Each re ort ~preseyrfs Ihesuspicion,
opinion or observdion of dse.mdividusl reporlcr. Gust and cftcct relaoonsh~pshave not been,qlabhshcd m rhe vast ma orily of repotts submmed. T l!”
e qiormmhoncontainedin thesa
reprrh to theIkdlh Canadais raw informnlion and has notbeen sciwtitlcdly or olherwise verlhed as 10 Lwuscand effw i’”rclahonshlp by}leahh Canada scientists. On] & smrrll
of advwsc reaction~ {~ortssubntikd
~i:~
ofsysfmxedadvemsrcacliomare reported IO Usepro ram, conscqsrm!iy thisinforerea!ionmuslno{ be USC!10dmate li!cinc]dence
~ corr{ains unpubldsed data and is prowled to YOU WItll sheunderstanding (hat this dasaWI 1be used only
acmrtma man u!kclrercrsrnreincluded in this nnrrmsr~ ki,sunmlsr
..,, ’,.,,.. ..$ ....:,
Ihrreauot.DrrsgSurvedkancc, “Ilscrapcu[ic Producls Progrsemrm.
-u-.
w in.vour.immedia!e ~rguizslion...~ reduced by: Advclse rug.lkadionRopmling-Unh.
April 12, 1999
Page 2 of 14
. . ... .. .-..+>.-..,,,-
CrrnadirsnAdverse Dnsg R~action Monitoring Program
Summarv of Reporled Adverse hug Reactions
Active [ngrcdicnf: Celirizlne
AII Reports received and entered into database before April 12,1999
Case report
number
Sex
Age
DW
Dosage
Duration
of treattnent
Drug
Outcome
Dose of drug
Involvement
form
na In–e
R
~
55 Year(s)
0088178
Suspccteel
REACTINE
Sy.~lem Orgun Ckms:
CARDIOVASCULAR
<
m
u
+
H
3
t-l
Reeovcred
without stquel ae
ldalc
I~
WHO Adverw Rewlion
HEART DISORDER
DYSPNOEA
DISORDERS, GENERAL
RESPIRATORY SYSTEM DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
CHEST
TIGHTNESS
OF
CrrrrcmuitaW
D
ANTIBIOTIC(S)
%
.
w
(sJ
ACIGTYLSALICYLIC
ATEF/OLOL
HEPARIN
Trmhncnf
Treatswnf
+
P
fi 0088803
D
z
NITROGLYCERIN
Treatmcnf
Tretrtment
ACID ENT CT
3s)Year(9)
Recovmed wifhout scquelae
Female
05 Day(s)
PROZAC
RESPIRATORY SYSTEM DISORDERS
HEART RATE AND RHYTHM DISORDERS
REACTINE
Dosageform 1 Daily
DYSPNOEA
TACHYCARDIA
13 Day(s)
1.00 Dosage l’orm I Daily
Suspected
Syskw Organ Clrms:
WHO A&erse
RESPIRATORY SYSTEM DISORDERS
HEART
RATE AND RHYTHM DISORDERS
DYSPNOE?A
i4 Year(s)
1.00
Srslpccted
WHO Adverse Reaction Term:
Sy.wn Organ Class:
01167S4
Term:
Reaction
Term:
TACHYCARDIA
Unkrrown
Female
Suspected
REACTINE
120 Milligrams
System Organ Class:
WHO Adverse Reacfion Term:
HEART RATE AND RHYTHM DISORDERS
PSYCHIATRIC DISORDERS
TACHYCARDIA
SUICIDE ATTEMPT
TREMOR
CENT’R& PERIPH NERVOUS SYSTEM DISORDERS
PSYCHIATRIC
PSEUDOEPHEDRINE
DISORDERS
HCL
l%st dose
SOMNOLENCE
I Day(s)
Cosscmoi!anf
360 Milligmrns
First dose
,and 10 a le~r extent Iaypcrsons. Each rc ors reprwcn{s the suspicion,
CAVEAT. The vast majofily of repofts on wl~ich [his summary is based we submitted by hcallh plactjtioners
e mforrnalion
contained in these
opinion err observrWon of theindividwd repwtcr. Gmse and effect rclatiorrships have nol been eslabhsbe-din the vast mrqority.of reporn wbmitte.d.‘Tt!”
April 12,
vcritied as to eriuse and effect rwlntlonshtp by -Healdl Canada scientists. On] oa smrdl
wports @ the lleal~h (hnadri is raw irnforrnation and has no! been seicntificidly or olherwise
F/e+rorhwbrnitted
roportrorsof su ccted adverse react$ns are rep m!ed to the pro rant, cmnsequently !$is inform~tirm must no! bc used to csfimak +e incidence of adverw lcac~ons.
%issummary corrtmnsrmp.bhshed data and ispro”ided to YOUWIIJSttte unde*ndln6
lhatlh~d:~~w:,!~:fl~
only
maoeuhca mrmufachrswrs me mehrded o-I thss summ ar
-“
.1
i
Advmse~rugReactio,iRe pottingUnil,
Bureau tiDmgSurveiUanW&~c{apeutic.Pro-duc&Programme,.
. .=.+=.W,;:.S..=X+,.A...pag~~fi!!4.
‘~\you~hrn?diate~~g&h{iokhdu~,&b},:
1999
%.,+&,-
...
Canadian Adverse Drug
Monitoring Program
Summaryof Reported Adverse Dru~ Reactions
Retiction
Active Ingredient: Cetirizme
All Reports received nssdenlered into ddfibage before April 12,1999
Case report
number
Agc
Drug
name
sex
Dosnge
form
Duration of trcatrncnt
Drug
Involvement
Outcome
Dose of drug
i+
61
~ 0116771
H
<
r-l
u
Wcowmd with sequelae
Femdc
26
REACTINE
-i
2
r-l
-o
m
P
w
0116801
1+
L
N
BODY AS A WHOLE - GENERAL DISORDERS
VASCULAR (EXTRACARDIAC) DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
RIGORS
68 Year(3)
MALAISE
Crm[inuingcm Drug
Corrtomihml
20 Milligrams
Daily
Cmsconiilaut
10 Milligrams
Daily
O!hrr
20 Milligrams 2
Daily
Ikcwewd
Female
Suspected
REACTLNE
Syslem Organ Class:
10 Milligrams
WHO Adverse Reuction
wi[hou[ seqwk
Fimt duw
Term:-
PALPITATION
DISORDERS
!hsri~ctcd
5 Milligmns
Daily
WHO A/verse Reuction Term.-
HEART RATE AND RHYTHM
DISORDERS
PALPITATION
Concoenhs)t
ACETAMINOPHEN
40Year(s)
g
FLUSHING
System Organ CIars:
0116802
10Milligrams Dtiily
SJWem Organ Class:
HEART RATE AND RHYTHM
RENEDIL
D
3
Suspected
WHO Adverse Reaction Term:
LOSEC
PLENDIL
PREPULSID
D
Dry(s)
1000 Milligrams
Daily
Reoovered
wilhout sequelae
~emrde
REACTINE
$Wem Organ Class:
RESPIIUTORY SYSTEM
DISORDERS
CARDIOVASCULAR DISORDERS, GENERAL
SKIN AND APPENDAGES DISORDERS
} Day(s)
Srrspee(t4
10MW@ams
Firs4
dose
WHO Adverse Reuction Term:
BREATHING DIFFICULT
HYPOTENSION
URTICARIA ACUTE
CAVEAT
The vast majority of rcprm em which dlis summary is based arc subtni(ted by health pracli[ioners and to a lesser cxterrl Iaypersons. Each re ort reprcseyl.sfbc suspicion,
opinion or ob.serva{ion of lhe individual reporter. Cmmc an~ et%.ct relationships have not been esmblisfscdin the vast majority of reports submitted. T (’w mforrrrts(]oncanlairred in dlese
repor[s @ the Heidfh Canada is raw infomlation and has not bear seiwstiihlly or olherwiw verified as to cause and etkct relationship by Health Canada seicntiWs. On] oa small
sc reactions are reported to tic pro rant, oonsequen[iy thisinformation
amass
not be used 10 esairnatesly incidence
of adversereaclions.I/~or@subn)itted
r~PorfJon of~s~~edadt,er
(hat this dala WI 1be used only
ar~ . %issurnnsar y con!ains unpublished data and is prpvidedtoyouW* theuarlers!rmding
arm~rst[cIs n}anufactuferq are nrchrded in this summ
fi ,% ..~
%’k.youm meshte ,org~tton+Boduced
by~ .~Adverse. {uSRcac~ionWportmg. Un~t, 13urears-ofDntg Sumelllat}uj.Thcrfipeur@Producw
Prograrnsnc?.., ,.,:, +w-:.-=+..,T,T. ~.w.zx=~~.
L
April 12, 1999
W-
Page4 of 14
.-., , . ..?,W<;.i
Adverse Dmg ReactionMonitoring
Progmm
Sutnnxsry o!’Reported Adverse Drug Reactions
Active Ingredient: Cetirizure
All Reports received and entered into dntssbasebefore April 12, 1999
Canadian
Case report
number
m
r-l
B 0116820
Age
Drug
Sex
name
Dosage
II
u
of treatment
38 Year(s)
of drug
!hqcclcd
Reuction
suspected
al
WHO Adverse Reuction Term:
GASTRO-intestinal
SYSTEM DISORDERS
VASCULAR (EXTRACARDIAC) DISORDERS
NAUSEA
w
F
~ 0116842
HEART FWTE AND
FLUSHING
PALPITATION
RHYTHM DISORDERS
Male
-..
Smpectrd
1 Day(s)
REACTINE
ltecwepf wi[hout seqsfdw
.
IU Miltigranrs Daily
System Organ Claw:
WHO Adverse Reucfion Term:
SKIN AND APPENDAGES DISORDERS
HIVES
CONDITION AGGRAVATED
BODY AS A
WHOLE
44Year(s)
0116847
. GENERAL
DISORDERS
Not yd fcwvcrcft
Male
24 HOUIS(S)
REACTINE
$yslem
Organ
Suspected
50Year(s)
$Wem
TerwI:
Unknown
2 Year(s)
Suspected
Organ Class:
LIVER AND BILIARY SYSTEM DISORDERS
DroB
ISI Milligmrrrs Daily
+
o
WHO Adverse Reuction Term:
to
LIVER ENLARGEMENT
b)
ACETAMINOPHEN
Clmhnuifig on
AMITRWTYLINE
Continuing on Drug
CotlcomiMrt
NIZATIDINE
Continuing on DrIIg
Concomitant
TI?RFENADINE
-d
CONVULSIONS
Female
REACTINE
U3
fn
10 Miliigrasrss Daily
WHO Adverse Reaction
Clusx
CENTR & PERIPH NERVOUS SYSTEM DISORDERS
0116849
m
5 Milligrams
Syslem Organ Class.”
D
n
UI
-n
w
LIJ
.
11 Ye*s]
Ui
u)
K
Term:
-0
m
3
D
-u
,; m
j
WHO #verse
RATE AND
REACTINE
N
Outcome
PALPITATION
NAUSEA
FLUSHING
RHYTHM DISORDERS
GASTRO-INTESTINAL SYSTEM DISORDERS
VASCULAR (EXTRACARDIAC) DISORDERS
D
Dose
Itwovwed wi[hms[ scquclac
4-5 Day(s)
HEART
2
m
Involvement
Female
Syslem Organ Ckzss:
-1
Drug
form
LAMISIL
<
Duration
Cn
Concomitant
&
b
co
1-
-J
Otk
-a
1-
P
.
CAV.EAT: The vast,majwily yf r$qorts on which lhis summary is bawd are .@mitted by hcahh practitioners and [o a lc~r Sxtent Iaypcrwns. .Dach fe WI reprcv+ts the suspicion,
opnuon or observalton of the u~dwldurnlreporter. Ciswe and effect wlatlonshtps have noI been twabltshed in the vast maysf!ty ofrepons submmed. T Kc usformmjon contained in (hese
April 12, 1999
reports to (he Hcalfh Canada is raw irsfounrdirm and has not bear scientifically or oihenvise verifk~ as to cause and effect rt+ationshIp by Healti
Canfida
scie.ntiws. Onl I R small
ro ortioa of sus ~ed adverse reactions ale reporlcd to the pro ram, consequcnily this in fomlation must not be used 10 eslimate flusincidence of ndvcrse reac[ions. I/c orkswbrnhkd
fhisdarswiflbe ussdonly —.. — .-. Page 5 of 14
included in this sunun . %hissismrnary corrtainstrnpublisbed data and is provided to you wi,hk underaiandingthat
~y ‘halmm~tica~mmufac~rersare
..<.G*
.-%
+=+xv&mywtimmed*k*tgmkatio*.*md&+y4dvef=
%~Re86WRqortig4mil;Bwreauo&Dfu~MvtiManmrThem@[b-P,dwe&-F,,%,m,i,,,esii.
- . :.*> 74G?5?=—--zsit-. ..+c~....
lb
m
Adverse Dnsg Reac[ion Monitoring Progmm
Summary of Re orted Adverse Dru~ Reactions
Active \ rsgrcdiessl:Cctirlzme
All Reports received and en(ered into dnhbnse before April 12,1999
Canadian
Case report
number
Sex
Age
Drug
Dura[ion of treatment
u
s
r-l
D
-u
m
w
Rewvered,i:vitlmst scquelac
WHO
BODY AS A WHOLE GASTRO-JNTESTINAL
GASTRO-INTESTINAL
BODY AS A WHOLE GASTRO-WfESTINAL
CORTICOSTEROI
D(S)
GAVISCON
llY car s
L 0116883
GENERAL
SYSTEM
SYSTEM
GENERAL
SYSTEM
L
Sysfem Organ
3
Term;
Treatrncn!
Trsa(mcnt
Male
Unknown
3 Week(s)
SYSTEM
DISORDERS
S Milligt,ams Daily
Suspected
WHO
Class:
CENTR & PERIPH NERVOUS
PSYCHIATIUC DISORDERS
PSYCHIATRIC DISORDERS
SAURIL
TEGRETOL
Adverse kac(ior~
EFFICACY, LACK OF
ABDOMINAL PAIN
HYPERSALIVATION
CONDITION AGGIUAVATED
DIARRHOEA
DISORDERS
DISORDERS
DJSORDERS
DISORDERS
DISORDERS
REACYI’INE
N
D
‘m
10 Milligrams D~iiy
Suspected
Syskm Organ Ckm:
•1
Outcome
Dose of slrug
Female
REACTINE
II
involvement
form
i%
~ 0116850
l-l
<
Dosnge
n~n-e
Drug
Adver.re Reacfion
APHASIA
-
Term:
MOTOR
LETHARGY
SOCIAL DEGENERATION
Concomitant
Concomitant
lltc vat mtijority ~f t~porls on which this surnmiuy )s based arc sulrmi{kxl by hculth pracl,ilione{s and ks a le.wercrilcnl Iuypcrswrss.,Ilachfc orl represents Ihc ~spicion,
opuuon or obswvalion of IIIc.nsdw!dual reporlcr. Cau= and cffccl rclnfionships hmw not been cstnbhshcdm (he vafi majorl!y-of reports subrnmed. “1”
ftc Wformation oontamcd in [hcsc
cause andeffeclrelatmn$h~p by Health
Canadarwentisls 011( a small
IepoIts w dre Health Canada M law mrormahoa rmd has not been wimr[ifically or olhcrwisc verilie,d as 1SS
ro ottion of w wmd adverse reactions me reported to the pro am, conaeqrsentty this islfomi~ton mual nol be ssstd to estirnate tile incidenec
of isdvcrse rwdons. &~orLcsubmi[fecl
By$wmmcet!,ic%manufacmrersmincl.dti
in Ihiss.rnrnsu~ %rissusnrnary corrtains.npubhshed data arsdisprovided to you witi lhesrndsmumding dmtttrisslatawl Lbe used only
~.,wat [email protected]@io3fOdwtiy;y; ;Adveswz Iu@leaGdoss Repurti@Jnit@ureau
d Drug Suzveillmu,-~crap~
[i~hdwc~.ProgralIime:
- J, J= + .“+Y==+.,~ZL*-’*=~
CAV,EAT:
April 12, 1999
Page_60f 14
y:fir.,~ ,,.,:!
‘-w..+=7s-@=+-
—
%
fIPR
13
’99
?
●
✎
✎
✎
✛
RECEIVED
‘m
13.
‘m
11: 42Flrl
W3
FR B DRUG SURUEILLRNCE
VJ
RPR.
14:46
TIME
613
957
D335
TO lt31861E14817
P. 137
\
d
Adverse
Summa~A:r~ee
Canadian
All
Reports
received
Dosage
and
Duration
Drug
Reaction
Monitoring
Drugz
orted
Adverse
T ngx-edient:
Cetiri=ne
entered
into
database
of
Program
Reactions
bt?fore
Drug
treatment
April 12,1999
Involvement
Dose of
Outcome
drug
form
Not Wd rccoved
5 Milligrams
Suspccled
Day<s>
2
WHO
Daily
FACE OEDEMA
RDERS
FIERAIDISORDERS
DISORDERS
LIPS SWELLING NON-SPECIFIC
ERYTHEMA
Continuing
on
Drug
ConcomiMrrt
1503 Milligrams
8 Dosage form Daily
Daily
Cors[inuirsg
on
Drug
Coneomitmrt
Continuing
on
Drug
Concomitant
32S Milligram
Daily
Daily
Contix~uix~~
on
Drug
Concomitant
2 Milligrams
Contirsuin~
on
Drug
Corrcomknnt
2 Milligrams
Daily
‘.. R~vcred
...“=
23-4
Suqsectcd
Day(s)
TIONAL
“X30NAL
SYSTEM
ar y
is based
czffcsct
me en
relatio
CONFUS1ON
SHAKING
DISORDERS
~EIN
are
scientifically
su bmittcd
nsh ips have
or
Term:
LIGHT-HEADED FEELING
HYPOGLYCEMIA
BLOOD SUGAR DECREASED
DISORDERS
DISORDERS
DISORDERS
Its
BUS
without scque]ae
10Milligrams Daily
WHO Adverse Reaction
SYSTEM
I)US
y
Adverse Reaction Term:
Gntinuin=
Continuing
Continuing
Continuing
on
on
on
on
Drug
Drug
Drug
Drug
Concomitant
Continuing
on
Drug
Concomitant
Continuing
on
Drug
Coneomitaul
Continuing
on
Drug
Concomttwrt
b y
not
otherwise
h=alth
practition
Concomihrsl
1 Dosage form 3 Daily
Concomifarst
Concomitant
c~s
ancl
to
a I=sscr
=xknl
Milligrams
Daily
3,75 Milligrams
Daily
Iaypcrsons. ,Each repo~ represents Ihc susiicion,
b==rs estab 1ishe d In the vast
m ajority
of reports submmed. The mformatiors ccm(mrred in [hese
v=ri ficxi as to cause
and
effect
rel ationshus by Health
Canada scientists. Only a ssrmll
April 12, 1999
%
xl
:Wy-?+m..4*--.:&?-#.&%%-:+
y.!*
Case
report
Drug
sex
Age
?1
REACTIFJE
S’sf
em
Organ
URINARY
130DY
AS
SKl_N
AND
FORTE
CLass:
SYSTEM
A
~OLE
APPENDAGES
DISOIZD
- GENE
Dl
ATASOIL
ATROVENT
ENTROPHEN
IMODXUM
TRILAFON
1-
- ..
l#S124
31
MaIe
Sy.stenz
Organ
CZass:
CENTR
&
PERIl?H
NERVOUS
METAESOLIC
AND
NUZX?XTI<
META130LIC
AND
NUZTRITI<
PSYCHIATRIC
DISORDERS
CENTR
&
PERIPH
NERVOU=
ACET’AMINOFHXZ=+
W1’17H
CODIZ1
17LUT1CASONE
17LUVOXAM1NE
lNSULIN
N
lNSUILIN
R
SODIUM
CROMOGLYCATE
ZOPIC_LONE
majority
of- r-eports
on
which
this
summary
I
the- Indlvl-dual
reporter.
Cause
and
eff
of
:ports
to the Health
Canada
AS raw
~n~ormatxon
and
has not been
roportion
of sus
ected
adverse
rcactlons
are reported
to the pro
in this
sumrnar
harmac-utica
T manufactu.rer5
are included
m.sn~~aze.wcgg-a.mt==x texw Ml?rwd w=+d .-b.y&&%cb-=r.Sa. i%..
% .W..?i%+-. a‘%%rz-w.uta+i
AV-EA-r:
pinion
--6 +%->. .. .-M$<
+$%-$,-$==-,.7.,- ?==k-sw-.%
vear<.s>
REACTYNE
D
3
or
The
vast
observation
Eil
,
Case report
number
Adverse Drug Reaction Monitoring
program
Swnnmry o f Repwled AdverseDru$ Rmctions
Active [ngreslient: Cetirizlne
All Reports received and entered into dtrhbase before April 12, 1999
Canadian
%
90118284
H
<
m
u
Age
Sex
26 Y ear(s)
Female
Drug
nnme
Dosage
fos-m
Duration of trerslment
$ysfcm
H
D
?0118536
P
w
?/
10Milligrams Daily
Other
Othrr
SELDANE
Other
Recovered wilhou( sequebe.
Female
27 Year(9)
2 Day(s)
REACTINE
Suspechxt
40 Milligrams
Daily
WHO Adverse Reaction Tertn:
System Oi-gun Clmw
CENTR & PERIPH NERVOUS SYSTEM
..
h
%
m
HEADACHE
HISMANAL
1P
“
Outcome
WHO Adver.w Reaction Term:
SYSTEM DISORDERS
BENADRYL
m
Dose of drug
Urf@wwn
Or-gun Class:
CENTR & PEFUPH NERVOUS
z
II
Involvement
Suspected
REACTINE
-1
Drug
DILANTIN
DISORDERS
Colllinuing cm Drug
CONVULSIONS
Cmtcomilnnt
350 Milligrams
Daily
.
RI
Unknown
Fcmrdc
a 0118702
Suspected
REACTINE
WHO Adverse Reac\ion Term:
Organ Class;
COLLAGEN DISORDERS
COLLAGEN DISORDERS
$mtetn
LUPUS ERYTHEMATOSUS
SYSTEMIC
ANTINUCLEAR FACTOR TEST POSITIVE
Femmle
45 Year(s)
0118890
D~ily
Remwwed wilhou( sequclae
same dny
ZYRTEC
Suapceted
10 Milligrams
Firs!dose
$Wem Organ Class:
WHO Adverse Reuction Term:
PSYCHIATRIC
SLEEPINESS
DISORDERS
CAVEAT The vast nlajofity of rcpods on which (hissummary is bawd iire submi[kd by health prac[~tiom+s and 10 a k~w~xtenf laypcrsons. -Each rcpo~t wprc~nts [he suspicion,
oprnion of observation of ~heindividual wporter. Cause and effect ~cla!ionships have not been.cslabhshed nt lhe vasl majortly of reporrs submdtcd. The mfoIplfitio.nconlaincd in d]ew
repor;ssotie Health Canada is raw in formti(ims aml has not been Scwtificnlly or otierwis verified as (n ease and ctlccl relationship by Iiedth Canada scienl!s~. Oilly a small
rdonof sos edcd adversereactionsare reparlcd 10 the pro ram, eosmequern!y [his information must notbe rss@ ta cslimale Ihe mcidcoee of adverse reactions. Rc errs submitted
mmary aanlains unpublished da!a end is provided to you with the nndcrslanding lhal (ti:s dara WI! I be used only
&~icflnsanufaeUJmraare
included in this susnso
_>,,,.,, , .. ,.,>..,,* ~. ~ri...A
. ~ .. WI irr,your.isnmcdiatemrganiz.ation.,,.Prodwmd by: AdvecS% rtlg.
“ni~BureauofDrug
s\iweillm&OTltertipeulic
Pm~ucM [I(ogral]]rne.
.
??%ionlkporting
.
M
s
April 12, 1999
-.
.. .
Y-!ageg.of
!4
.+. ~~.
Adverse Drug Reaction Monitoring !%qyarn
Summary of Rc ortc.1 Adverse Drug React~ons
Csmadian
Acth’e Yugredient:
All
Case report
number
m
3
HU119202
2
u
,,
Age
Drug
name
Sex
Dosage
form
Duration of treatment
1%
3
m
.
1+
w
Organ Class:
PSYCHIATRIC DISORDERS
PSYCHIATRIC DISORDERS
PSYCHIATRIC DISORDERS
BODY AS A WHOLE - GENERAL
PSYCHIATRIC DISORDERS
Dhy(s)
Su$pectd
10 Milligrams
II
Daily
WHO Adverse Reaetion Term:
PANIC REACTION
ANXIETY REACTION
PARANOID REACTION
HOT FLUSHES
INSOMNIA
DISORDERS
MARVELON
FLONASE
e
+
..
Concomitant
Daily
O[her
AMITRIPTYLINE
Treatment
2S Milligrams
ATIVAN SUBL
.3Yeafment
J Milligrams As necessary ..,,
Suspected
10 Milligrams
h
+J 0119494
57 Yw-u(s)
Organ Class:
HEART RATE AND RHYTHM
.
Recovered without sequelae
7 Day(s)
Daily
WHO Adverse Ilecaction Tertn:
CHEST FULLNESS OF
ATRIAL FLUITEIV FIBRILLATION
TACHYCARDIA
BODY AS A WHOLE - GENERAL DISORDERS
HEART RATE AND RHYTHM DISORDERS
DISORDERS
Drog
LOSEC
(hn!inuing
PREMARIN
Continuing on Drrsg
Cwrcomilsrrst
PULMICORT
VENTOLIN
Continuing on Drug
Concomilrmt
Gmdrsu ing on Drug
Concomilnnt
ZOPICLONE
Continuingon Drug
Crmcomilmrt
CLARITJN
Daily
Female
REACTINE
$wtem
%
; x
Outcome
Dose of drug
Not yct~cwvertd
$6
SyVern
-1
Drug Involvement
Female
REACTINE
n
Cetirizine
Reports recciwst a nd errtcrcd into slatabase before April 12,1999
on
Concomitant
0.625 Milligrams
7.5 Milligrams
Daily
Daily
Other
CAVtMT The vasfimujoriiy ~f r$porLson which Ibis summmy is bawd ale.submitkd by herdlh praclilioncm and to u ksw extent lnyperswrs. Each repcsrl represents the suspicion,
opinion or observation ofthc nrdwdsml repotter. CauW and effecr relationships ilave not hews established in (be vimI ma”ority ofreporis submitted. The information oonhtirwd in these
repor[s [o tie HealIll Canmhi is raw informirlion and has IWI been scit.m[ifically or otherwise vcrilkd as to cause and effet / wlalionshtp by Hcrdlh (lmadst wie}]lis(s. 0111’ a small
April
o or[irm of’ su
ctcd adverse reactions are rcpoded lo Ihc pro ra!n, corsseqrscn
lly [his information nws[ no{ be used (o es{imatc the incidence of adyer= rcsrclions. F+orts submiWd
,K:$arrnaceu[ic%nanitfad,trersm
nsciudcd
tisissumrnm
%l~.%~mav,.~.n!?insu? p.ubl~hcd
~rod,,wd in~y:
Ad,,er,e;
Waand isprpvidcd P~.o,q~vi~!lhctl nde~[ldlng.~~a!!his.4?@.~~,!.k!~1wd ... . . onl$,,~a,%,.x,.,=pag.e
..j.
. . . ....<
wt[ in your isnmediwe oiganizistioil,
rug cactlon Reporhng ‘WI, Bnrcau o t Drug hvdlancc,
ITwiptmc Produiks Progritmnte.
12, 1999
J,Q,of.lq
______
-
canaciian
Adverse
All
Reports
Drug
Reaction
Monitoring
of Reported
Adverse
Dru~
Active
Ingredient:
Cetirizlne
and
entered
into
database
Surnrnary
received
F%wgram
Reactions
before
12,1999
April
D
Dosage
form
Duration
of
treatment
D rug
Involvement
Dose
-0
m
outcome
of drug
L
Rceovewd ~ithou[ scquclsw
s us pcctesi
1 Day(s>
10 Milligrams
JWHO Adverse Rettclion
M
AC>
D1
SO~ERS
DISOFKDERS
IhA DISOR13ERS
DISO=ERS
S SYSTEM
5RAL
DISORDERS
2ERS
SRAL
IM
IM
EIS>
a
1b
Term;
TACHYCARDIA
z
FLUSHING
PALPITATION
33 URNING SENSATION
FEVER
FACE OEDEMA
-n
m
m
w
xl
c
c1
ii
Trealmersl
~
k
..-
-:>-.
Wexac<s>
i%
Sus’pccted
5 Nlilligrarns
E\’cry
other day
L-
7
r
WHO Adverse Reaction Term:
CHEST PAIN
CARDIAC ARREST
_l_ORSADE DE POINTES
DISORDERS
DISORDERS
DISORDERS
650 Milligrams
Coracomilnnt
:--r
M
G
*1
Daily
D
z
.R
0
1
+
w
Daily
U2
Ul
Concomitant
Coaacomitrnrsl
25 hfiltigrams 1 Daily
Concomitant
30 hfilligrams 1 Daily
ii
m’
Coraeomihrrs!
2,6 Milligrams 3
H
u-l
Daily
-1
Not yel r~covered
Day
2
<s>
10 Milligrams
Suspected
D~ily
Adverse Reaction Term:
WHO
DISORDERS
0
ARRHYTHMIA
NODAL
Urrknmtw
Day
4
<s)
S us Petted
10 Milligmms
Daily
WHO Adverse Reuctiotl Term.-
FEMALE
‘ is based
-ace
?fect
relatlonsh
~n scientifllcally
114TERMENSTRUAL
Continuing
011
Drug
BLEEDING
Coraa20mi(mN
-u
P
ii
submitted
ips have
or
by
not
otherwise
b
al
health
be=n
practitioners
and
to a lesser
extent
]aypcrsons, Each m ortwprcsesus the suspicion,
established
in the vast
majority
o f reports submitted. “rI c reformation
eon[ained in these
“
veriflteci
as to cause
and
=ffT=ct
relationship
by Hedh Canad# scientisk Onl ~a small
int’orrraation
m ust not b= used
to ~stirrsate theincidence of adverse fcactions. #e orlssubrnitted
consequently
this
o%~i&&urnrraary
ccsntain:s
unpubl
ished
data
and
is provided
IrUg Rea&tion
Reporting
Un’itp
13ure”iiu
of Dru~’Surveillance.
lES31
QEl
to
you
‘t-l~cr
with theundemla,,di,,g lhatthi~dati!t:fi
ap”mstic
l’roducts ~ro~ramme,
~uwd.nly
.
April 12, 1999
.. .
,.-.. .“
.,p?ge ] I
,,
CIf14
A
sex
Age
Drug
n=me
Case
report
R number
mm
i$ 9c5~0
fi
m
~
3
r-l
38
JF~malc
7/
~ear<s~
REACTINE
s’s
tern
HEART
VASCULAR
HEART
CENTR
130DY
D
-u
m
URINARY
.G
Or%qun
RATE
class:
AND
RHYTHM
<EXTRACARDIAC
FU%TE
AND
RHYTHM
&
PERIF’H
NERVOUS
AS
A TWHOI-E
- GENE=
SYSTEM
DISOR13EF
I
I
S
13 ENADRYL
77
iF%0970
&
N
D
3
Ma]
Year<s)
e
REACTINE
organ
s’s tem
130DY
AS
A
HEART
=TE
HEART
RATE
ACETY~SALICYLIC
ALCOHOL
ATENOILOlNKD?EDIY?lNE
NITRONG
SR
89
121452
CETXRIZZINE
S’y.srem
HEART
Czass :
WHOLE
AND
AND
ACID
- GENEW
RHYTHM
RHYTHM
ENT
CT
-1
1
Male
Year<s>
Or~un
IU4TE
CZassY
AND
RHYTHM
1
Female
121?305
REACIXNE
JSYS temz Organ
REPRODUCTIVE
CZass:
DISORDERS.
‘rRIPHASIL
..
!AVE3AT:
pinion
>ports
, -,. .. ....
. . . , -..-..,-.
.. .. ...!, ----
..- .....
.... ..=---- -. -----=
. .
The
or
vasq
observation
majority
of
the-
of
reports
indivi-dual
on
whicl~
reporter-
to the Health
Canada
1s raw
information
roportion
of s-us ected
adverse
react l-ens are
.X*
.—--- m,
harm
ac~u t~.caY - m~.nwfa~+r~rs
a~.~. ~ncl~de~
. ....+..... -. --EY=
Pro’dueed
-imrriedlate
‘-or~an~zatloti.
{i&- In your
this summary
Cause
and
is 1
efTecI
and
has not been
s{
rqpor~ed
to the pro
r
In .-~~cs, sum mar &.ru:’
--“b-y”: -Ad’w”erse
El
Canadian
1.
.,
Adverse
Sutmnaw
.
ofl?e
Monitoring
Program
ortcd AdverseDru Reactions
Drug Reaction
Active Yogrcdicssl: Cetiriz f ne
All Rcporfs received and en[ercd info database before April 12, 1999
Case report
number
m
m
~ 0122315
Drug
n~nlc
sex
Age
Dosage
form
Durittion
of Irefitment
sequclae
Rccoveredtiwi(hrwt
I:cmdc
H
<
II
Srstipecte4
BECLOFORTE
w
Syslewi Organ Class:
WHO Aherse
RESPIRATORY
RESPIRATORY
RESPIRATORY
THROAT IRRITATION
SYSTEM DISORDERS
SYSTEM DISORDERS
SYSTEM DISORDERS
-u
.m
Suspected
RESPIRATORY
RESPIRATORY
SYSTEM
SYSTEM
D
3
RESPIRATORY SYSTEM
RESPIRATORY SYSTEM
RESPIRATORY SYSTEM
VENTOLIN
DISORDERS
DISORDERS
DISORDERS
System Organ C[ass:
RESPIRATORY SYSTEM DISORDERS
RESPIRATORY SYSTEM DISORDERS
RESPIRATORY SYSTEM DISORDERS
PULMICORT INHALER
53 Yeaf(s)
0122316
WHO Adverie Reaction
THROAT SORE
THROAT IRRITATION
COUGHING
Suspected
Orgurr Class:
LIDEX
.
m
u
m
c
m
‘-----
Term:
D
g
m
As rwcossary
WHO Adverse Reaction Term:
THROAT SORE
THROAT IRRITATION
COUGHING
200 tvlicrogmrns 2 Daily
O(her
.“
-1
0
NOI ycl fC4WCfCd
Suspecfcd
REPRODUCTIVE DISORDERS, MALE
BODY AS A WHOLE - GENERAL DISORDERS
BODY AS A WHOLE - GENERAL DISORDERS
APPLICATION SITE DISORDERS
.
.
Male
REACTINE
$Wenl
Daily
Tem:
THROAT SORE
THROAT IRRITATION
COUGH~G
2 Dosage brrn 2 Daily
suspected
t)lSORDERS
DISORDERS
RESPIRATORY SYSTEM DJSORDERS
SEREVENT
Syftenl Organ Class:
*
F
;
I-u
Tertn:
10 Milligrams
WHO Adverse Readion
SyJlen)Orgnn Class:
#
w
.
Reaclion
COUGHING
THROAT SORE
REACTINE
D
G
u)
T]
-i
1+
3
r-l
D
~ 2
F
u
Outcome
Dose of drug
Drug Involvement
10 Milligrmns
Dnily
&
F
WHO Adverse Reaction i%n:
03
m
&
&
:
PERINEAL PAIN MALE
PAIN
COND1TION AGGRAVATED
SKIN NODULE
Trca(meof
$,
.-.
-u
G
.
CAVEAT: Thevmlmajority ~fmpurts
opsmon or obscrvat ion of [he mdmdual
&
srnVAich [his sumINaeyis basedsw Submilkd by herdth prtsc[ifioaa-sand to a @er extent Iaypmorss, -Each re orl represgrds (Iw suspicion.
reporler.
Cause ISnd e ffcct rclotionsh ips have n~ bcsm es[ablishcd in lhe vast majority of repnr[s submslterl. T fte tfl form atron contain ed in hew
reports to tie Heat[h Canada is raw informmion and has no~ been sciclllilictllly or ofl~txwise verified as 10ertuse and effect retabrshtp by l+eollh Crmadti sc!cnlm. On] B smal!
roporkon ofsus eti
adverse rerwions sire reported to the pro Mm, conqucn!ly
[his information musl not be used trJ eslimate the incideiwx of adverse reactions. P$rortssubrnitted
harmaeeuticaY manufachsrers are inchsdcstiu [his sumt-mar . I]is sul!unary contains unpublished rkstriand IS provided to you with the mrdershmdmg thai this da{a WI I be tssed only
!Min.your. imrncdia!e orgimti~a~ion_rroduccd by: Adverse 8 Iug
l)rogrtimlnc.
~ RGWWOn Rcporfing .Unil, Durean of Dnsg Surveillance, Thefapculic I)rOStUCIS
.,
..-,
‘----
m
April 12, 1999
Page
-.
120fl
.
X
.4’
Cmtdim AdvemeDrug Reaction Monitoring Program
Summary of Reporied Adverse hug Reactions
Cetirizine
Active Ingredient:
All Reporfs received and entered iuto dahbnse before April 12, 1999
Case reporl
XJ number
m
m
f1012232(l
&
w
-i
Age
Drug
ntrme
17Y c~r(s)
Su.specWd
PLATELET, BLEEDING & CLOTTfNG DISORDERS
PLATELET, BLEEDTNG & CLOTTING DISORDERS
PLATELET, BLEED~G & CLOTTING DISORDERS
VISION DISORDERS
RANITIDINE
D
-El
aJ
P
J-d
32 Year(s)
~ 0122322
l-u
D
x
Syslem Organ
Rceovwed willlout sequelae
‘..
Clcm:
& CLOTTING DISORDERS
& CLOTTING
DISORDERS
O.sntinuiag on Drug
PLATELET, BLEEDING
Suspccled
& CLOTTING
DISORDERS
PLATELET, BLEEDING
& CLOTTING
DISORDERS
60 hlilligrarns 3 Daily
NOSEBLEED
Not yet recoverrd
Female
Srr9pecWd
REACTINE
5 MiUigrann 2 Da~Jy
WHO Adverse Reaction Term:
Class:
PSYCHIATRIC DISORDERS
ATROVENT
BECLOFORTE
TICLOPIDINE
D4ily
Terns:
WHO Adverse Reaction Term:
Sysfem Organ Class:
Sys(em Orgun
IO hfilligrams
Reaclion
NOSEBLEED
Suspected
69 Year(s)
2 Dosageform Daily
NOSEBLEED
WHO Arfverse
Class:
SUDAFED
VENTOLIN
NOSEBLEED
Suspeclerl
-./“
WHO A dver.se Reuction Term:
PLATELET,BLEEDING
REACTINE
0122324
I DosRge rorm 2 Daily
WHO Adverse Reuction Term:
System Organ Class:
Orgml
Concomitant
Suspected
PLATELET,BLEEDING
FLONASE
*stem
U@mown
j{
THROMBOCYTOPENIA
NOSEBLEED
PETECHIAE
CONJUNCTIVAL
HAEMORRFJAGE
Female
CO-TRIMOXAZOLE
‘-
10 Milligrwns Daily
Treatment
CORTICOSTEROID(S)
t-
~ %
Outcome
Dose of drug
WHO Adverse Reaction Term:
system Org(ltl CIUSJ:
I-1
Drug Involvement
Mide
REACTINE
H
3
i
Duration of treatment
Dosrtge
form
Sex
Cosrlinuing on Drug
DEPRESSION
Concomilanf
Dosrrgcform 3 Daily
Cosrcomitsrrf
Dosage form 3 Daily
Concwuitant
250 Milligrams 2 Daily
Concurnibmt
Dosage fo~m 4 Daily
CAV-EAI:TIJcvasl, majofily ~f r$por(s on which this summary ~sbased are submitted by hciilttt praclidoners and (o a lesserextent Iaypersons .Each re orl rcpr~nls [he suspicion,
opmlon or observsrtlon O! thq rndw!,du.alrepylcr. Cause surdcfkct relationships have not been established in the vasI majority of reports submsucd. ‘l#e infomtahomcontaincd in these
been sciendfscrdly or otherwise verified as to cause and effect relatiwrshqr by Health Canada scientists. 0ss1 a small
wyror[$~ tbe HealA Canada LSraw nrfofmrdlorrand has rssst
roportron ofsu
ected adverse rcacllons are rcpor[ed 10 Utc pro ram, eonscquendy this inforrna!ion must nol be used to es~inlale(he incidence of rrd~erse reactiou~ {r~ortssubrni(ied
wmaceuttca
“sswnmrrry comains rrnpuhlishecldat~ and is provided. to..you.wlh the ut@c~$@?dmg ~haf~l@ da[fi WI.! bc .u%d,.or!lk- --.7 mm-mfachsrers are mchsded m this sumnra I
‘hl’krttmon
Repor[irrg Uni[, 13tsrtvnrofthrg
Srsrveillarwe, Tllerapcu!icProducL% ProgrHmnte.
.‘!$l%r your irnm ediate orgmrizadon. Psoshsced by: Advw-se\ rug
April 12, 1999
,._,-P@ge~.3.Qf
14
Canadian
Adverse
Summa~A~~i~=e
Reports
All
received
Dosage
rO
and
Duration
Drug
Reaction
Monitoring
Reactions
orted
Adverse
Drug
9 -gx-edient:
~etirizcin~
entem-ed
into
database
before
of
treatment
April
12,1999
X nvolvemenl
Ontcome
Dose of drug
E-m
Recovered Nithout scquelae
1 Day{s)
10 Milligrmns
S uspccfed
Daily
?
WHO Adverse Reuc!ion Tetw:
DEPRESSION
s
Unknown
Suspected
IERAL
lERAL
3
WHO Adverse Reaction Term:
FATIGUE EXTREME
CRYING ABNORMAL
BAD MOOD
DISORDERS
D1 SOFLDERS
Recovered without sequelae
2
S ucpected
Week(s)
WHO
10 Milligranis Dnily
Adverse Reac(ion Term:
CONFUSION
HYPONATRAEMIA
CrJ ncomkmt
s
~lONAIL
DISOR-DERS
concomitant
Concont{fa:lt
Treatment
Total No. of reports
Total No. of reports witllfhtal
43
outconse
L
is based
are
submitted
by health
relations
ips h ave
not been
~effect
=en
sciersti ilcall y or o thezrwise
veri
ry
H
to a lesser
~xtcrsliaypwsmns.
CLxhw orI rcpre~nts (he suspicion,
v ast
m ajority
of repojls submitted. Tl!”
e mformatton conlamed m these
April 12, 1999
as
to
cause
and
effect
relatiomhlp
by HcmlIIICanada scientists. Onl a s[nalt
must
not
tDe used
to estirn
de tileincidence of adverse reactions. I$orlssubntil,ed
data and
is prov
id=d to YOU.Wi~ Ulewdwtandiw ‘hatu)is‘ala ‘V’!:he‘Wd.only.. ... .. ...... , ‘?W 1.4‘f’4
of
Drug
Surveillance.
Therapeutic
l%oduc~ %ogmmme.
--.
practitioners
and
estab 1ished
in the
t3ed
consequently
th is information
<urnrrs
ary contains
u npublish=d
,-R~porting-Ursit,
13uredu
a ction
%o%~~
rug
m
Drug
Program
,
m
x
Case
report
number
Drug
name
HI 22325
A
u
-1
sex
Age
40
Yea
X-<s)
%
+stezn
OPgan
PSYCHIATRIC
H
3
Class:
DISORDERS
Fcrnaie
‘ ‘122326
D
-u
m
P
l-d
%
+
~1 22495
N
3
REAC!TINE
Organ
S=ystenz
AS
A
130DY
AS
A
BODY
PSYCHXATRXC
. .. .
.. . .
. . ... ..,
-,. . ....+
- ...._&.
Class:
XWHOLE
WTHOLE
- C3ENE13
- GE3VJ3~
DISORDERS
Male
REACTINE
System
Organ
PSYCHTATRXC
META1301-IC
MET
HOTR1
MEPRAZIN
MULTIVITAMINE<S)
0XA2ZEPAM
NORMAL
SAIJINE
2
,,...,= ,,.
. .
Male
VI
REACTINE
~: AVEAT:
The
vast
~.pinion
or observation
~eports
to the
Health
proportion
of s.us e
Class:
DISORDERS
AND
NUTRITIC
E
‘-
majority
of reports
on which
this
summary
i
individual
reporter.
Cause
and
cffc
raw
information
and
has
not
been
reactions
are reported
co
the pro.
u ad””rs”
factu rcrs ar,e...in
clud,cd. in this sum m ar
organ’i~atiun.
‘--rrodu’ccd
by:->
Adverse~ rC of
Canada
--- ,:-.,’,.._:: ;,- .......
... ....,,.-.,.
&~#
.. .. . .- :~~i~&3rnlacqtztlcaY
your
Xlnnxe-dfate
the
is