-- E.J. Mundell
FRIDAY, Jan. 25 (HealthDay News) -- The U.S. Food and Drug
Administration late Friday approved three new medications to help
people battle type 2 diabetes.
All three drugs contain a new active ingredient, alogliptin,
either alone or in combination with other, previously approved
medications. The newly approved drugs include Nesina (alogliptin),
Kazano (alogliptin plus metformin) and Oseni (alogliptin plus
pioglitazone), the FDA said in a news release.
"Controlling blood sugar levels is very important in the overall treatment and care of diabetes," Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in the statement. "Alogliptin helps stimulate the release of insulin after a meal, which leads to better blood sugar control."
More than 24 million people in the United States are currently
affected by type 2 diabetes, which is closely linked with obesity.
In the type 2 form of the disease, people gradually develop
resistance to insulin or fail to produce enough of the hormone,
resulting in rising blood sugar levels. That can lead to other
health problems, such as heart disease, vision problems and neural
or kidney dysfunction.
The FDA urges that the new medications be used in combination
with a healthy diet and exercise to help bring diabetes under
control. All of the drugs underwent study either as stand-alone
products or used alongside standard diabetes medications such as
sulfonyureas or insulin.
In the case of Nesina, the drug showed safety and effectiveness
across 14 clinical trials, involving more than 8,500 patients,
according to the FDA. The most common side effects included stuffy
or runny nose, headache, and upper respiratory tract
Kazano's safety and effectiveness were tested in four clinical
trials involving more than 2,500 patients. Side effects included
those seen with Nesina, as well as diarrhea, high blood pressure
and back pain, the FDA said. The agency is also requesting that a
"boxed warning" be included on Kazano's labeling, highlighting the
potential risk of lactic acidosis (lactic acid buildup in the
blood), which can occur in products containing metformin.
Oseni was studied in four clinical trials involving more than
1,500 patients, the FDA noted. Side effects were similar to those
seen with Nesina, as well as back pain. Oseni's labeling will also
carry a boxed warning, this time cautioning users about the risk
for heart failure that accompanies drugs containing
The drugs will also be subject to what are known as
"post-marketing studies," aimed at spotting any emerging risks. For
example, studies looking at heart and liver issues are mandated for
Nesina, while studies focused on potential liver and pancreas
problems are mandated for both Kazano and Oseni, the FDA said.
All three drugs are distributed by Takeda Pharmaceuticals
America Inc., of Deerfield, Ill.
Find out more about type 2 diabetes at the
American Diabetes Association.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
Copyright © EBSCO Publishing. All rights reserved.