A ZAIEM I AOUINTI R DAGHFOUS M LAKHAL S ELAIDLI National Centre of Pharmacovigilance Tunis VR6 INTRODUCTION Contrast Media CM are generally well tolerated Adverse ID: 484863
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SERIOUS ADVERSE REACTIONS TO CONTRAST MEDIA
A ZAIEM, I AOUINTI, R DAGHFOUS, M LAKHAL, S ELAIDLINational Centre of Pharmacovigilance, Tunis
VR6Slide2
INTRODUCTION
Contrast Media (CM) are generally well tolerated. Adverse
reaction
reported
with
CM are in
most
cases
mild
toxic
reactions
such
as
heat
sensation,
nausea
and
vomiting
.
Although
serious
adverse
reactions
to CM are rare,
these
reactions
are
exceptionally
notified
to pharmacovigilance
authorities
.Slide3
OBJECTIVE
The aim of this study was to examine the features of serious adverse reactions associated with CM and reported to the Tunisian PharmacoVigilance Centre. Slide4
MATERIALS and METHODS
A retrospective study assessed in the Tunisian Pharmacovigilance Centre. All serious adverse reactions associated with contrast media were notified.
Study period: from January 2009 to December 2011.
The notifications were analyzed according to the French method of imputation.
The seriousness of the cases was evaluated according to the WHO criteria.Slide5
RESULTS
Five cases of serious adverse reactions associated with CM were colleged. Three males and two females. Age: 18 – 65 years. Telebrix®
(
ioxitalamate
) incriminated in four cases.
Omnipaque
®
(
iohexol
)
in one case.
Two cases of hypersensitivity reaction: a generalized
erythema
and an anaphylactic shock.
Two cases of cardiovascular effect :
thrombophlebitis
.
One case of general reaction : loss of consciousness without hemodynamic troubles.
The outcome was favorable in all cases.Slide6
Case n° 1
A 18-year-old maleMedical history of Hodgkin diseaseA CT scan in January 2009During the injection of CM (ioxitalamate) pain
,
burning sensation
at injection site and a
tumefaction
of hand and forearm
The radiography of left hand was normal
A
veinous
echodoppler
showed a
thrombosis of superficial cephalic vein
The treatment:
sulodexide
,
antalgic
and anti-inflammatory drugs
The outcome: favorable in 20 days Slide7
Case n°2:
A 54-year-old maleMedical history of
unprecised
urological
disease
A
uro
CT scan in
November
2008
At
the
start
of injection of CM (
ioxitalamate
)
pain
,
erythema
and
induration
at
injection site on the
pathway
of the
vein
.
The
treatment
was
not
precised
.
The
outcome
favorable in one
week
.
Slide8
Case n°3
A 65-year-old femaleMedical history of arterial hypertension, allergic rhinitis and conjunctivitis.An intravenous urography in April 2009.Few minutes after CM (ioxitalamate
) injection
abdominal pain
,
nausea
,
vomiting
and
tingling of lower limbs
.
Fifteen minutes later
lost of consciousness
and
fall of arterial pressure
The therapeutic management:
oxygenotherapy
, intravenous fluid, adrenaline, and
corticotherapy
.
The hemodynamic constants stabilized in 30 minutes.
The patient recovered in 24 hours.Slide9
Case n°4
A 55-year-old femaleMedical history of allergy
to
penicillin
and
allergic
rhinitis
A
brain
scan for
headache
in 2008.
During
injection of CM (
ioxitalamate
)
lost
of
consciousness
for few minutes.
No
cutaneous
eruption
,
nor
hemodynamic
troubles.Slide10
Case n°5
A 18-year-old maleTreated for scoliosis since january 2010 by anti
inflammatory
drugs
A
scopy
with
injection of CM (
iohexol
) of
lumbar
vertebrae
in
order
to
infiltrate
cortivazol
in
december
2010.
Ten
minutes
later
generalized
erythema
and
pruritus
.
Treatment
:
corticotherapy
.
The
outcome
favorable in 15 minutes.Slide11
Sexe
AgeexplorationCM
Reaction
Delay
Case 1
M
18
CT scan
Ioxitalamate
Thrombophlebitis
During injection
Case 2
M
54
Uro
CT scan
Ioxitalamate
Thrombophlebitis
During injection
Case 3
F
65
Intravenous
urography
Ioxitalamate
Anaphylactic
shock
Few minutes after injection
Case 4
F
55
Brain scan
Ioxitalamate
Loss of
consciousness
During injection
Case 5
M
18
Scopy
of lumbar vertebrae
Iohexol
Generalized
erythema
and
pruritus
Ten minutes
after injectionSlide12
Discussion
CM are classified on the basis of their physical and chemical characteristics including osmolality, ionization in solution, and chemical structure. Four classes are commercially available:Ionic monomers high
osmolar
CM (exp:
ioxitalamate
),
Non ionic monomers low
osmolar
CM(exp:
iohexol
),
Ionic
dimers
low
osmolar
CM,
Non ionic
dimers
iso
osmolar
CM. Slide13
In our study,
four cases were associated with ioxitalamate (an ionic monomer).Ionic CM
are more often involved in adverse reactions than nonionic CM especially for minor adverse effects.
The frequency of mild anaphylactic reactions ranges from
3.8% to 12.7% in high-
osmolar
ionic CM
0.7% to 3.1% in low-
osmolar
nonionic CM
The risk for serious or severe reactions (anaphylaxis grade 3) ranges from
0.1% to 0.4% with ionic contrast material
0.02% to 0.04% with nonionic contrast materialSlide14
In our study, three cases of immediate reaction were notified without possible determination of the mechanism (allergologic explorations were not performed).
Immediate reactions happening during the hour following the CM injection are frequently in relation with a toxic mechanism (histamino release and complement activation). The immuno-allergic mechanism (IgE dependant) is rarely reported. Slide15
In our study, we reported two cases of thrombophlebitis associated with
ioxitalamate (ionic CM).Although CM can have anticoagulant and anti-platelet properties as cardiovascular effects, some studies focused on their possible thrombotic effects.These effects seem to be due to endothelial injury, secretion of prothrombotic agent and platelet activation.CM alteration of endothelial cells appears to be related to
osmolatility
but not to
ionicity
. Slide16
Conclusion
Our study presented five cases of serious adverse reaction to contrast media which mainly occurred after ioxitalamate administration.Slide17
References Dewachter
P, Mouton-Faivre C, Laroche D, Clément D. Allergie immédiate aux produits de contraste iodés et prévention des réactions. Revue de Médecine Interne 2009;30:872–881.Trcka J, Schmidt C, Seitz CS, Bröcker EB, Gross GE,
Trautmann
A. Anaphylaxis to Iodinated Contrast Material:
Nonallergic
Hypersensitivity or
IgE
-Mediated Allergy? AJR American journal of
roentgenology
2008;190:666-70.
Clément
O.
Iatrogénie
des
produits
de
contraste
. Journal de
radiologie
2006;86:567-72.
Esplugas
E,
Cequier
A,
Gomez
-Hospital JA, Del Blanco BG,
Jara
F. Comparative Tolerability of Contrast Media Used for Coronary Interventions
.
Drug Safety 2002; 25:1079-1098.Slide18
Thank you