10
fhea.com Fitzgerald Health Education Associates
™
May 2016
News Briefs
Rare But Serious Skin Reactions
Associated with Olanzapine
The FDA is warning that the antipsychotic
medicine olanzapine (Zyprexa, Zyprexa
Zydis, Zyprexa Relprevv, Symbyax) can cause
a rare but serious skin reaction that can
progress to affect other parts of the body.
The agency is adding a new warning to the
drug labels for all olanzapine-containing
products that describes the condition,
known as drug reaction with eosinophilia
and systemic symptoms (DRESS). The FDA's
database identified 23 cases of DRESS asso-
ciated with olanzapine that were reported
worldwide since 1996 (when the first olanza-
pine-containing product was approved).
DRESS may start as a rash that spreads to
all parts of the body, and includes fever
and swollen lymph nodes and a swollen
face. DRESS causes a higher-than-normal
number of eosinophils and can result in
injury to organs including the liver, kidneys,
lungs, heart, or pancreas, and can lead to
death. DRESS is a potentially fatal drug re-
action with a mortality rate of up to 10%.
The FDA statement said healthcare profes-
sionals should immediately stop treatment
with olanzapine if DRESS is suspected. There is
no specific treatment for DRESS; early recogni-
tion of the syndrome is important for the
management of DRESS. Discontinuation of
the offending agent as soon as possible and
supportive care are required. Treatment with
systemic corticosteroids should be considered
in cases with extensive organ involvement.
For more information,
click here .
Increased Risk of Leg, Foot Amputations
Associated with Canagliflozin
The FDA has warned the public about safe-
ty results from an ongoing clinical trial that
found an increase in leg and foot amputa-
tions, mostly affecting the toes, in patients
treated with the type 2 diabetes medica-
tion canagliflozin (Invokana, Invokamet).
The agency is not yet able to determine
whether canagliflozin increases the risk of
leg and foot amputations and is investigat-
ing this new safety issue and will update
the public when more is known.
Canagliflozin is one of a class of drugs
called sodium-glucose cotransporter-2
(SGLT2) inhibitors. These medications lower
blood sugar by causing the kidneys to re-
move sugar from the body through the
urine. Canagliflozin is available as a single-
ingredient product (Invokana) or in combi-
nation with metformin (Invokamet).
The ongoing trial is the Canagliflozin Car-
diovascular Assessment Study (CANVAS).
To date, patients in the trial have been fol-
lowed for an average of 4.5 years. Data
suggest an increased risk of leg and foot
amputations; amputations occurred about
twice as often in patients treated with
canagliflozin compared with patients treat-
ed with placebo. A second, similar trial
evaluating canagliflozin has not shown the
same risks of increased leg and foot ampu-
tations to date.
The FDA is continuing to monitor the
data.
For more information,
click here .
•
FDA