Navigation Links
FDA Approves 3 New Drugs for Type 2 Diabetes
Date:1/28/2013

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 infections.

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 pioglitazone.

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.

More information

Find out more about type 2 diabetes at the American Diabetes Association.

-- E.J. Mundell

SOURCE: Jan. 25, 2013, news release, U.S. Food and Drug Administration


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves 1st Skin Patch to Combat Migraines
2. Environmental Protection Agency Approves MOMS by OdorXit as a Disinfectant
3. FDA Approves New Type of Flu Vaccine
4. FDA Approves New Once-a-Day HIV Pill
5. FDA Approves Flu Vaccine for Coming Season
6. FDA Approves 2nd New Weight-Loss Drug
7. FDA Approves 1st Pill to Help Prevent HIV Infection
8. FDA Approves First New Weight-Loss Drug in More Than a Decade
9. FDA Approves SonixGPS Needle Guidance Technology for Vascular Access Procedures
10. FDA Approves Combo Shot for Meningitis, Hib in Kids
11. FDA Approves Generic Versions of Plavix
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves 3 New Drugs for Type 2 Diabetes
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... ... 24, 2016 , ... Strategic Capital Partners, LLC (SCP) in ... investment capital for emerging technology companies. SCP has delivered investment events and ... more than a million dollars of capital investment for five companies. ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 26, 2016 Story Highlights: ... models within the health care industry is causing providers ... , Deloitte offers a suite of solutions for ... impacting efficient cost optimization: labor resource analysis, revenue cycle ... facilitate better outcomes and better economics ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
Breaking Medicine Technology: