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Fitzgerald Health Education Associates, Inc., April 2015 fhea.com
References
1. Express Scripts. A nation in pain. Focusing on U.S. opioid
trends for treatment of short-term and longer-term pain . De-
c
ember 9, 2014. Available at http://lab.express-scripts.com/publica-
tions/a-nation-in-pain
2. Thomas K. Patients prescribed narcotic painkillers use more of
them for longer, study finds.
New York Times . December 9, 2014.
FDA Panel Recommends New Safety
Warnings for Two Diabetes Meds
Most members of an FDA advisory panel voted to
recommend that two dipeptidyl peptidase-4 in-
hibitors (DPP-4s), saxagliptin (Onglyza) and alogliptin
(Nesina), have label updates that include information
about new safety issues that have recently become
known from results of two cardiovascular outcomes
studies first presented at the European Society of
Cardiology meeting in 2013 and later published in
the New England Journal of Medicine.
The panelists voted to update the saxagliptin la-
beling, primarily on the increased risk for heart fail-
ure; the group also wanted to see data on the trend
toward higher all-cause mortality. There was a 27%
increase in the rate of the first event of hospitaliza-
tion for heart failure and a potential increased risk
for all-cause mortality, the panel members said.
The committee members also voted to update the
labeling of alogliptin with new data about heart fail-
ure, which they were concerned could potentially be
a class-wide problem.
One panel member noted that although there are
issues with both saxagliptin and alogliptin, clinicians
should not come away with the idea that there are
huge problems with these medications; rather, they
should understand that there are things to be care-
ful about when prescribing.
•
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ontinued from page 23