-- Scott Roberts
FRIDAY, Aug. 1, 2014 (HealthDay News) -- Jardiance
(empagliflozin) has been approved by the U.S. Food and Drug
Administration to treat type 2 diabetes, which accounts for some 90
percent of diabetes cases in the United States, the agency said
Friday in a news release.
Affecting some 26 million people in the United States, the
disease can lead to complications including heart disease,
blindness and nerve and kidney damage, the FDA said.
Jardiance, from a class of drugs called "sodium glucose
co-transporter 2 inhibitors," is designed to block re-absorption of
blood sugar by the kidneys. Its safety and effectiveness were
evaluated in clinical studies involving 4,480 people with type 2
The drug should not be used to treat type 1 diabetes, in people
with severe kidney impairment, among people with increased ketones
in the blood or urine, or in people on dialysis, the FDA said.
The agency said it has ordered several post-marketing studies of
the new drug, including an evaluation of its effects on the
The most common side effects are urinary tract infection and
female genital infection. The drug also may cause dehydration,
leading to a significant drop in blood pressure, the FDA said.
Jardiance is distributed by Boehringer Ingelheim
Pharmaceuticals, based in Ridgefield, Conn.
FDAto learn more.
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