-- E.J. Mundell
FRIDAY, Aug. 1, 2014 (HealthDay News) -- The U.S. Food and Drug
Administration announced on Friday that it approved a new drug,
Jardiance, to help fight type 2 diabetes.
Jardiance (empagliflozin) "can be used alone or added to
existing treatment regimens to control blood sugar levels in the
overall management of diabetes," Dr. Curtis Rosebraugh, director of
the Office of Drug Evaluation II in the FDA's Center for Drug
Evaluation and Research, said in an agency statement.
The FDA also recommended that Jardiance be used along with
lifestyle changes, such as eating a healthy diet and exercising
regularly. The combination of medication and lifestyle modification
may improve blood sugar management for people with type 2 diabetes,
Over 26 million Americans are currently affected by type 2
diabetes, which accounts for about 90 percent of cases of diabetes,
according to the agency.
Jardiance, made by Connecticut-based Boehringer Ingelheim
Pharmaceuticals, falls into the class of diabetes medicines known
as "sodium glucose co-transporter 2 (SGLT2) inhibitors." These
drugs work by stopping blood sugar, or glucose, from getting
reabsorbed by the kidneys. That means that more glucose is excreted
by the kidneys and blood sugar levels go down, the FDA explained.
Other drugs in this class of medications include Invokana
(canagliflozin) and Farxiga (dapagliflozin).
The agency said the safety and effectiveness of Jardiance was
tested in seven clinical trials involving almost 4,500 people with
type 2 diabetes. The studies showed that Jardiance improved blood
sugar levels compared to a "dummy" placebo drug.
The drug has also been studied for use alongside other
medications, such as metformin, sulfonylureas, pioglitazone (Actos)
and insulin. The FDA stressed that it is ordering post-marketing
studies on Jardiance, with a focus on any potential cardiovascular
effects, as well as safety and effectiveness in children.
Jardiance can trigger dehydration, which can cause low blood
pressure, dizziness and impaired kidney function, the FDA added.
This means that elderly people and those with already impaired
kidney function may be at heightened risk when taking Jardiance.
The drug should not be used by people with type 1 diabetes,
according to the FDA.
The most common side effects seen with Jardiance included
urinary tract infections and female genital infections, the FDA
Find out more about type 2 diabetes at the
American Diabetes Association.
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