FDA Approves Nesina, Kazano and Oseni Diabetes Medications

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In January 2013, the U.S. Food and Drug Administration (FDA) approved alogliptin (Nesina), alogliptin with metformin hydrochloride (Kazano) and alogliptin with pioglitazone (Oseni) to treat adults with type 2 diabetes. These oral medications, which are available in tablet form, are approved for use with diet and exercise measures to help improve blood sugar control.

According to the FDA's Center for Drug Evaluation and Research, the new active ingredient in the medications—alogliptin—stimulates insulin production after eating, improving blood sugar levels. Nesina, Kazano and Oseni may be used alone or with other diabetes treatments like insulin and sulfonylureas.

In clinical trials, the drugs resulted in reduced HbA1c (glycosylated hemoglobin) levels—indicating improvements in blood glucose control. They should not be used in people with type 1 diabetes or people who have elevated blood or urine ketones (diabetic ketoacidosis).

Although Nesina, Kazano and Oseni were found to be safe and effective, the FDA is requiring additional studies to monitor for serious side effects, including cardiovascular conditions, liver abnormalities, severe pancreatitis and hypersensitivity. The potential safety and effectiveness of these medications in children with type 2 diabetes is also being studied.

Kazano and Oseni carry Boxed Warnings—Kazano for lactic acidosis risk related to metformin, and Oseni for heart failure risk related to pioglitazone. Common side effects associated with these medications include upper respiratory tract infection, runny or stuffy nose and headache. Kazano also may cause sore throat, diarrhea, high blood pressure (hypertension), back pain and urinary tract infection (UTI). Other side effects associated with Oseni include sore throat and back pain.

If you have type 2 diabetes, talk to your health care team about these medications, and watch for the results of ongoing studies and research.

Source: U.S. Food and Drug Administration (FDA)

Publication Review By: the Editorial Staff at Healthcommunities.com

Published: 28 Jan 2013

Last Modified: 10 Mar 2015