Takeda Pharmaceuticals Gets FDA approval for “new” Diabetes Medications. (Drug company puts a new coat of paint on the same house)

Prescription spilled

In the world of diabetes medications, Takeda Pharmaceuticals is best known for the drug Actos. The drug was plagued by links to bladder tumors and bladder cancer, congestive heart failure, edema, macular edema, increased liver enzymes, fractures and fractures.

Takeda lost its monopoly on Actos in August, 2012 when the FDA approved generic forms of the medication.
Takeda’s answer to losing revenue from the genericizing of Actos was to release “new” medications for type 2 diabetes. The FDA has now approved their new entries into the diabetes medication arsenal. Don’t get too excited….as we’ve seen all of these medication classes before.

Three more drugs to add to the diabetes pill box : Nesina, Kazano, and Oseni. All have the base of alogliptin.
Alogliptin is another drug in the class DPP-4 inhibitors. (Merck’s Januvia is a DPP-4 inhibitor). Side effects for DPP-4 inhibitors have included severe pancreatitis, serious allergic reactions, kidney complications, increased liver enzymes.
DPP-4 inhibitors regulate the pancreas’ insulin release after eating. Their mechanism to lower blood sugar includes increased insulin and decreased liver glycogen production.

The “New” medications:
Nesina: pure alogliptin
Kazano: alogliptin with metformin
Oseni: alogliptin with actos

The trials involved a relatively small number of participants. Trials on the core drug alogliptin in Nesina involved 8500 participants. Kasano; 2500 participants. Oseni: 1500 participants. And then…FDA approval.

Nesina: Drops A1C .4-.6% after 6 months
Kazano: Drops A1C .4-.6% over metformin alone (2 drugs in Kazano)
Oseni: Drops A1C an extra .4-.6% over Actos alone (2 drugs in Oseni)

Side effects for the “new” drugs include:
Nesina: upper respiratory infection, headaches, runny or stuffy nose, back pain
Kazano: same as above with addition of diarrhea, GI upset, hypertension
Oseni: same as above with black box warning for heart failure, liver abnormalities, severe pancreatitis, severe hypersensitivity…and let’s not forget that Actos was linked to bladder cancer.

There is a way to control blood sugar, drop A1C an average of 2 full points after only 8 weeks as well as lose weight and body fat, decrease cholesterol (LDL), triglycerides, blood pressure, insulin and increase Vitamin D and HDL cholesterol. There are ZERO SIDE EFFECTS with : The Metabolism Miracle or The Diabetes Miracle. http://www.thediabetesmiracle.com or http://www.themetabolismmiracle.com. Trial size: over 6000 patients. Currently used internationally and is a NY Times Bestselling program. Online support group: http://www.miracle-ville.com.

The Metabolism Miracle or The Diabetes Miracle: Zero side effects, 5 times the A1C drop of alogliptin in 1/3 the time, improvements in lipids and blood pressure, vitamin D, and weight and no need for FDA approval!

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About Diane Kress

Author of The New York Times Bestseller; The Metabolism Miracle, The Metabolism Miracle Cookbook, and The Diabetes Miracle. and The Metabolism Miracle, Revised Edition. Owner, developer, and administrator of The Metabolism Miracle's support site: www.Miracle-Ville.com. Registered Dietitian, Certified Diabetes Educator, www.themetabolismmiracle.com www.thediabetesmiracle.com www.miracle-ville.com Email: dietquestions@ymail.com
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