-- Scott Roberts
MONDAY, Jan. 28 (HealthDay News) -- Three new related drugs
designed to improve blood sugar control in people with type 2
diabetes have been approved by the U.S. Food and Drug
All three drugs contain a new active ingredient, alogliptin
(brand named Nesina), either by itself or with other previously
approved medications. In addition to Nesina, the agency approved
Kazano (alogliptin and metformin hydrocholoride) and Oseni
(alogliptin and pioglitazone).
Type 2 diabetes leads the body to resist insulin or to produce
insufficient amounts of the hormone, causing blood sugar to spike.
The disease affects about 24 million people in the United States,
accounting for more than 90 percent of diabetes cases, the FDA said
in a news release.
Nesina, either by itself or in combination with other
medications, was tested in 14 clinical studies involving some 8,500
people with type 2 diabetes. The new drugs should not be used by
people with type 1 diabetes, or by people who have high amounts of
ketones in the blood or urine, the FDA said.
The most common side effects of alogliptin included runny nose,
headache and upper respiratory tract infection. Additional adverse
reactions were reported among people who used the combination
Kazano's label will include a "black box" warning of the
possibility of lactic acidosis, a buildup of lactic acid in the
All of the new medications are distributed by Takeda
Pharmaceuticals America, based in Deerfield, Ill.
The FDA has more about
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