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fhea.com Fitzgerald Health Education Associates, Inc., May 2015
tions canagliflozin, dapagliflozin, and em-
pagliflozin may lead to ketoacidosis. The medica-
tions are in a class of drugs called sodium-glucose
cotransporter-2 (SGLT2) inhibitors (Table 1). The
agency's investigation will determine whether
changes are needed in the prescribing informa-
tion of these drugs.
According to the FDA, a search of the FDA Ad-
verse Event Reporting System database identified
20 cases of acidosis reported as diabetic ketoacido-
sis (DKA), ketoacidosis, or ketosis in patients treated
with SGLT2 inhibitors from March 2013 to June 6,
2014. All patients required emergency department
visits or hospitalization to treat ketoacidosis. Since
June 2014, the FDA has continued to receive addi-
tional adverse event reports for DKA and ketoacido-
sis in patients treated with SGLT2 inhibitors.
The FDA noted that the reported cases were not
typical for DKA because most patients had type 2
(not type 1) diabetes and their reported blood
sugar levels were only slightly increased com-
pared with typical DKA cases.
Healthcare professionals should evaluate pa-
tients for the presence of acidosis, including ke-
toacidosis, in patients experiencing difficulty
breathing, nausea, vomiting, abdominal pain, con-
fusion, and unusual fatigue or sleepiness. Discon-
tinue SGLT2 inhibitors if acidosis is confirmed and
take appropriate measures to correct the acidosis
and monitor blood glucose levels.
For more information, click here:
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ontinued from page 20
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Brand Name Active Ingredients
Invokana Canagliflozin
Invokamet Canagliflozin and metformin
Farxiga Dapagliflozin
Xigduo XR Dapagliflozin and metformin
extended-release
Jardiance Empagliflozin
Glyxambi Empagliflozin and linagliptin