Journal of Evidence-Based Medicine,
Год журнала:
2024,
Номер
17(4), С. 795 - 807
Опубликована: Дек. 1, 2024
This
study
aims
to
investigate
the
occurrence
of
adverse
events
associated
with
topiramate
by
analyzing
data
from
FDA
Adverse
Event
Reporting
System.
The
goal
is
provide
a
basis
for
safe
clinical
use
topiramate.
Frontiers in Pharmacology,
Год журнала:
2025,
Номер
16
Опубликована: Март 18, 2025
Tyrosine
kinase
inhibitors
(TKIs)
are
the
preferred
targeted
therapy
for
advanced
gastrointestinal
stromal
tumors
(GIST).
Ripretinib,
first
tyrosine
switch
control
inhibitor,
has
not
yet
been
extensively
studied
long-term
safety
in
large
populations.
This
study
evaluates
Ripretinib-related
adverse
events
(AEs)
real-world
applications
by
analyzing
data
from
FDA's
Adverse
Event
Reporting
System
(FAERS).
To
quantify
signals
of
AEs,
we
employed
several
disproportionality
analyses:
Odds
Ratio
(ROR),
Proportional
(PRR),
Bayesian
Confidence
Propagation
Neural
Network
(BCPNN),
and
Multi-item
Gamma
Poisson
Shrinker
(MGPS).
In
FAERS
database,
out
7,064,646
reports,
3,161
were
identified
as
related
to
Ripretinib
with
438
significant
terms.
The
most
common
reactions
tiredness,
hair
loss,
nausea,
constipation,
diarrhea,
loss
appetite,
palmar-plantar
erythrodysesthesia
syndrome,
vomiting.
These
align
medication
instructions
reports
corresponding
clinical
trials.
Notably,
label
includes
unexpected
AEs
such
"hepatic
neoplasm",
"hair
texture
abnormal",
"metastases
liver"
"red
blood
cell
count
decreased".
median
onset
time
was
99
days,
an
interquartile
range
27-245
days.
Most
cases
(26.74%,
n
=
165)
occurred
within
month
administration.
Our
findings
observations.
We
novel
signatures
indicating
that
prospective
studies
necessary
confirm
these
clarify
their
implications.
results
could
provide
valuable
evidence
guide
further
on
Ripretinib.
Frontiers in Pharmacology,
Год журнала:
2025,
Номер
16
Опубликована: Апрель 25, 2025
This
study
aimed
to
systematically
and
scientifically
investigate
the
potential
associations
between
use
of
fluoroquinolone
antibiotics
(ciprofloxacin,
levofloxacin,
moxifloxacin,
ofloxacin,
norfloxacin,
delafloxacin)
suicidal
thoughts
behaviors
using
data
from
Food
Drug
Administration
Adverse
Event
Reporting
System
(FAERS)
database.
The
FAERS
database
was
queried
first
quarter
2004
fourth
2023.
Disproportionality
analysis
conducted
reporting
odds
ratio
(ROR)
empirical
Bayes
geometric
mean
(EBGM).
A
total
737
cases
associated
with
fluoroquinolones
(FQs)
were
reported
in
during
period.
Overall,
FQs
did
not
demonstrate
a
disproportionate
increase
overall
(ROR:
0.74,
95%
CI:
0.69-0.79,
P
<
0.001;
EBGM05:
0.69).
Stratified
analyses
revealed
no
safety
signals
for
either
females
or
males.
However,
subgroup
by
age
groups
demonstrated
slightly
elevated
RORs
<18
years
group
1.51,
1.05-2.19,
=
0.03)
18-24
2.31,
1.75-3.06,
0.001),
although
EBGM05s
values
remained
below
two
both
populations.
No
significant
observed
other
groups.
does
indicate
an
signal
at
present.
Subgroup
slight
group;
however,
detected
based
on
these
Further
comprehensive
prospective
studies
are
necessary
confirm
validate
findings.
Postgraduate Medical Journal,
Год журнала:
2025,
Номер
unknown
Опубликована: Май 13, 2025
Abstract
Background
Factor
Xa
inhibitors
(FXaIs)
may
induce
nephrotoxicity
despite
their
FDA
approval
for
thrombotic
diseases,
which
has
raised
concerns
due
to
its
severe
consequences.
This
study
utilizes
the
FAERS
database
assess
potential
link
between
direct
FXaIs
and
nephrotoxicity.
Methods
Data
from
database,
spanning
third
quarter
of
2011
fourth
2023,
were
used
perform
a
disproportionality
analysis
on
Apixaban,
Edoxaban,
Rivaroxaban.
Disproportionality
statistical
processing
conducted
using
R
software.
Results
Descriptive
revealed
that
males
individuals
aged
65–85
are
more
susceptible
nephrotoxic
adverse
events.
The
indicated
all
three
drugs
associated
with
acute
renal
failure
renovascular
disorders,
Edoxaban
showing
strongest
correlation.
Conclusions
quantitatively
analysed
relative
risk
reactions
FXaIs,
emphasizing
importance
function
monitoring
these
medications.
results
indicate
significant
association
nephrotoxicity,
necessitating
closer
attention
use
recommending
additional
tests
drug
concentration
testing
high-risk
patients.
Frontiers in Pharmacology,
Год журнала:
2024,
Номер
15
Опубликована: Окт. 22, 2024
Background
Amiodarone
and
dronedarone
are
both
class
III
antiarrhythmic
medications
used
to
treat
arrhythmias.
The
objective
of
this
study
was
enhance
the
current
understanding
adverse
drug
reaction
(ADR)
associated
with
amiodarone
by
employing
data
mining
methods
on
U.S.
Food
Drug
Administration
Adverse
Event
Reporting
System
(FAERS),
providing
a
reference
for
safe
reasonable
clinical
use.
Methods
ADR
records
were
selected
searching
FAERS
database
from
2011
Q3
2023
Q3.
disproportionality
analysis
algorithms,
including
Odds
Ratio
(ROR),
Proportional
(PRR),
Bayesian
Confidence
Propagation
Neural
Network
(BCPNN),
Empirical
Geometric
Mean
(EBGM),
detect
signals
amiodarone-related
dronedarone-related
ADRs.
profiles
categorized
organ
toxicity
compared
through
Z-test
Fisher
exact
test.
Results
9,295
reports
specifically
mentioned
use
2,485
among
9,972,109
reports,
majority
ADRs
occurring
in
males
over
60
years
old.
United
States
responsible
highest
proportion
reported
Significant
system
classes
(SOC)
included
Cardiac
disorders,
Respiratory,
thoracic
mediastinal
Investigations,
etc.
At
preferred
terms
(PTs)
level,
more
frequent
interaction
(n
=
856),
hyperthyroidism
758),
dyspnoea
607),
while
atrial
fibrillation
371),
204),
blood
creatinine
increased
123).
Notably,
unexpected
ADRs,
electrocardiogram
T
wave
alternans
16;
EBGM05
231.27),
accessory
cardiac
pathway
11;
140),
thyroiditis
178;
125.91)
amiodarone,
ablation
31.86),
cardioversion
7;
22.69),
dysphagia
47;
3.6)
dronedarone,
uncovered
instructions.
also
revealed
significant
differences
showing
higher
proportions
but
lower
thyroid
amiodarone.
Conclusion
These
findings
underscore
significance
vigilantly
monitoring
comprehending
potential
risks
linked
dronedarone.
New
discovered
clear
thorough
these
drugs,
which
is
essential
clinicians
ensure
Research Square (Research Square),
Год журнала:
2024,
Номер
unknown
Опубликована: Май 15, 2024
AbstractBackground:
Amiodarone
is
a
class
III
antiarrhythmic
medication
used
to
treat
arrhythmias
for
decades.
The
objective
of
this
study
was
enhance
the
current
understanding
adverse
events
(AEs)
associated
with
Amiodarone
by
employing
data
mining
methods
on
US
Food
and
Drug
Administration
Adverse
Event
Reporting
System
(FAERS).
Methods:
The
AE
records
were
selected
searching
FDA
database
from
September
2014
2023.
disproportionality
analysis
algorithms,
including
reporting
odds
ratio
(ROR),
proportional
(PRR),
Bayesian
confidence
propagation
neural
network
(BCPNN)
empirical
Bayes
geometric
mean
(EBGM)
detected
signals
Amiodarone-related
events.
Results:
Among
8,595,344
reports,
7,841
specifically
mentioned
use,
majority
AEs
occurring
in
males
over
60
years
old.
United
States
responsible
highest
proportion
reported
AEs.
Reports
severe
outcomes,
hospitalization,
life-threatening
death,
notable.
Significant
system
organ
classes
(SOC)
included
“Cardiac
disorders”
(SOC:
10007541),
“Respiratory,
thoracic
mediastinal
10038731),
“Metabolism
nutrition
10027433),
etc.
significant
then
mapped
preferred
terms
such
as
“myxoedema
coma”
(n=108,
EBGM05=499.73),
“thyrotoxic
crisis”
(n=97,
EBGM05=194.83),
“mitochondrial
aspartate
aminotransferase
increased
”
(n=8,EBGM05=186.19),which
have
emerged
usually
patients
Amiodarone.
Of
note,
unexpected
AEs,
“thyroiditis”
(n=161,
EBGM05=127),
“electrocardiogram
T
wave
alternans”
(n=13,
EBGM05=236.29)
“iodine
overload”
(n=5,
EBGM05=152.03),
uncovered
label.
Conclusions:
These
findings
underscore
significance
vigilantly
monitoring
comprehending
potential
risks
linked
use.
Unexpected
discovered
made
thorough
drug,
which
essential
clinicians
ensure
safe
use
Expert Opinion on Drug Safety,
Год журнала:
2024,
Номер
unknown, С. 1 - 8
Опубликована: Дек. 12, 2024
Colchicine
is
widely
used
for
gout
and
familial
Mediterranean
fever
(FMF)
has
cardiovascular
benefits.
However,
it
linked
to
various
adverse
drug
reactions
(ADRs).
This
study
aimed
analyze
colchicine-related
ADRs
using
FAERS
data
safer
clinical
use.
Journal of Evidence-Based Medicine,
Год журнала:
2024,
Номер
17(4), С. 795 - 807
Опубликована: Дек. 1, 2024
This
study
aims
to
investigate
the
occurrence
of
adverse
events
associated
with
topiramate
by
analyzing
data
from
FDA
Adverse
Event
Reporting
System.
The
goal
is
provide
a
basis
for
safe
clinical
use
topiramate.