Analysis
of
Spontaneous
Postmarket
Case
Reports
Submitted
to
the
FDA
Regarding
Thromboembolic
Adverse
Events
and
JAK
Inhibitors
Published Research Download
Published Research Download
Analysis
of
Spontaneous
Postmarket
Case
Reports
Submitted
to
the
FDA
Regarding
Thromboembolic
Adverse
Events
and
JAK
Inhibitors
Key Points:
Potential
thromboemb
olic
safety
concerns
for
baricitinib,
a
Janus
kinase
(JAK)
inhibitor,
were
recently
raised
by
the
US
FDA.
The
FDA
has
previously
approved
two
other
JAK
inhibitors,
tofacitinib
and
ruxoliti nib,
but
has
not
issued
any
warnings
regarding
thromboemb
olic
safety
signals
for
these
two
medications.
A
systematic
review
of
the
FDA’s
Adverse
Event
Reporting
System
(FA
ERS)
found
elevat
ed
repor
ting
for
both
tofacitinib
and
ruxolitinib
for
certain
thromboembolic
adver
se
events,
suggesting
the
possibility
of
a
class-wide
issue.
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