Risk of drug-induced pericardial effusion: a disproportionality analysis of the FAERS database
BMC Pharmacology and Toxicology,
Год журнала:
2025,
Номер
26(1)
Опубликована: Фев. 7, 2025
By
using
the
FAERS
database,
we
aim
to
identify
and
assess
risk
signals
of
adverse
drug
events
(ADEs)
potentially
causing
pericardial
effusion,
inform
clinical
management
promote
rational
use.
We
obtained
reports
effusion
from
database
spanning
first
quarter
2004
second
2024,
identified
top
50
drugs
ranked
by
report
frequency
or
signal
strength.
Four
algorithms,
namely
reported
odds
ratio
(ROR),
proportional
reporting
(PRR),
Bayesian
confidence
propagation
neural
network
(BCPNN),
multi-item
gamma
Poisson
shrinker
(MGPS),
were
employed
for
detection
these
drugs.
Furthermore,
with
positive
signals,
conducted
sensitivity
analyses
Weibull
shape
parameter
test
perform
a
time
onset
(TTO)
analysis.
20,057
ADEs
related
involving
19,693
patients
The
patient
population
comprised
10,187
males
(51.7%)
7,939
females
(40.3%).
Adults
aged
18–65
years
largest
group
(7,798
cases,
39.6%).
Regarding
outcomes,
9,924
(50.4%)
experienced
hospitalization,
2,770
cases
(14.1%)
resulted
in
death.
Ranked
ROR
strength,
3
hydralazine
[ROR
(95%
CI):
27.11
(22.28–33)],
dasatinib
15.62
(14.07–17.33)],
mesalazine
8.99
(6.84–11.8)].
TTO
analysis
26
signals.
median
interquartile
range
(IQR)
earliest
were:
cytarabine
14
(7.5,38),
selexipag
14.5
(4.25,
157.75),
dabigatran
etexilate
29
(9,
229).
Most
exhibited
an
early
failure
type.
This
study
systematically
compiled
list
potential
risks
effusion.
There
is
significant
association
between
use
hydralazine,
dasatinib,
mesalazine.
Moreover,
more
common
groups
receiving
treatments
antineoplastic
immunomodulating
agents.
Язык: Английский
Runchangningshen paste activates NLRP6 inflammasome-mediated autophagy to stimulate colonic mucin-2 secretion and modulates mucosal microbiota in functional constipation
World Journal of Gastroenterology,
Год журнала:
2025,
Номер
31(9)
Опубликована: Фев. 18, 2025
Runchangningshen
paste
(RCNSP)
is
a
made
of
four
medicinal
and
edible
homologous
Chinese
medicine
mixed
with
honey.
It
known
for
its
ability
to
nourish
yin
blood
as
well
loosen
the
bowel
relieve
constipation.
The
pathophysiology
functional
constipation
(FC)
associated
reduction
in
mucin-2
(MUC2)
secretion
microbial
dysbiosis.
To
investigate
underlying
mechanism
RCNSP
against
FC
through
MUC2
gut
mucosal
microbiota.
Ultra-performance
liquid
chromatography
tandem
mass
spectrometry
characterized
composition
elucidate
material
basis
action.
model
was
induced
via
loperamide
gavage
(16
mg/kg)
twice
daily
7
days.
Applying
defecation
function
gastrointestinal
motility
assess
severity.
Hematoxylin
eosin
Alcian
blue-periodic
acid-schiff
staining
analyzed
colonic
morphology.
Transmission
electron
microscope
used
observe
ultrastructure
goblet
cells
(GCs).
Immunofluorescence
colocalization,
quantitative
PCR,
western
blot
assessed
impact
on
gene
protein
expression
within
NLRP6/autophagy
pathway.
16S
rDNA
employed
sequence
contained
12
components
potential
laxative
effects.
enhanced
function,
accelerated
motility,
maintained
integrity.
treatment
significantly
increased
GC
abundance
production
while
preserving
ultrastructure.
At
molecular
level,
colocalized
key
regulatory
proteins
modulated
mRNA
expressions
Through
sequencing
analysis,
altered
microbiota
composition.
Specifically,
it
beneficial
bacterial
strains
reducing
harmful
ones.
Simultaneously,
reduced
butyrate-producing
bacteria
like
Proteobacteria,
Enterobacteriaceae,
Blautia,
Eubacterium
decreased
hydrogen
sulfide-producing
species,
such
Prevotellaceae.
also
bile
acid-inhibiting
g_Eubacter_coprostanoligenes_group
Erysipelotrichaceae
increasing
acid-producing
Colidextribacter.
Our
findings
suggested
that
ameliorated
dual
mechanism:
stimulated
by
activating
NLRP6
inflammasome-mediated
autophagy
Язык: Английский
Risk assessment of the top 50 drugs associated with drug-induced orthostatic hypotension: a disproportionality analysis of the FAERS and JADER databases
Scientific Reports,
Год журнала:
2025,
Номер
15(1)
Опубликована: Март 26, 2025
To
use
the
FDA
Adverse
Event
Reporting
System
(FAERS)
database
to
identify
drugs
associated
with
orthostatic
hypotension.
event
reports
of
hypotension
from
Q1
2004
Q3
2024
were
obtained
FAERS
and
JADER
databases.
We
employed
algorithms
such
as
reporting
odds
ratio
(ROR),
proportional
(PRR),
Bayesian
confidence
propagation
neural
network
(BCPNN),
multi-item
gamma
Poisson
shrinker
(MGPS)
for
signal
detection.
was
used
validate
findings
analysis.
identified
15,737
adverse
events
hypotension,
involving
15,480
patients
The
patient
demographic
included
6,745
males
(43.5%)
7,248
females
(46.8%),
largest
group
comprising
adults
over
65
years
(7,654
cases,
49.4%).
three
highest
ROR
risk
signals
terazosin
[ROR
(95%
CI):
153.96
(124.57-190.28)],
rasagiline
37.46
(29.99–46.78)],
doxazosin
37.06
(31.32–43.86)].
Apomorphine,
abalopatine
levodopa
shortest
onset
time
Most
detection
results
verified
in
database.
Drugs
hypertension
still
focused
on
cardiovascular
nervous
system
drugs.
This
study
33
that
may
be
potentially
linked
Medical
workers
should
remain
vigilant
regarding
these
causing
Язык: Английский
Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part II
Journal of Clinical Psychopharmacology,
Год журнала:
2025,
Номер
unknown
Опубликована: Апрель 8, 2025
Abstract
Purpose/Background
This
is
the
second
part
of
a
2-part
article
that
proposes
improving
United
States
(US)
clozapine
package
insert.
Part
II
focuses
on
fatal
outcomes
and
5
boxed
warnings,
4
specifically
for
clozapine:
severe
neutropenia,
seizure,
orthostatic
hypotension
myocarditis,
1
all
antipsychotics
(elderly
with
dementia).
Methods
US
reports
to
World
Health
Organization's
global
pharmacovigilance
database
were
analyzed
from
clozapine's
introduction
January
15,
2023.
Findings/Results
The
was
top
reporter
worldwide
56,003
9587
associated
outcomes.
warnings
534
(218
131
seizures,
125
orthostasis,
36
24
cardiomyopathy,
0
mitral
valve
prolapse).
With
no
pneumonia
674
increased
white
blood
cell
count
(a
sign
infection)
596
After
considering
overlaps,
increases
in
explained
900
fatalities,
or
9.4%
Food
Drug
Administration
continues
focus
neutropenia
which
only
218
2.3%
outcomes,
whereas
97.7%
reported
clozapine-treated
patients
had
another
cause.
Implications/Conclusions
To
help
prevent
future
deaths
patients,
insert
should
during
infections.
offers
detailed
solutions
regarding
current
lack
warning
other
Supplementary
Material
includes
letters
support
124
non-US
experts
44
countries/regions
who
Parts
I
II.
Язык: Английский