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Nesina, Kazano & Oseni

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Nesina, Kazano and Oseni are incretin mimetics marketed by Takeda Pharmaceuticals to treat Type 2 diabetes. Side effects potentially associated with their use include an increased risk of pancreatic cancer and pancreatitis, as well as heart failure.

Alert! Alogliptin Labels Updated With Heart Failure Heart Failure Warning

In April 2016, the U.S. Food & Drug Administration (FDA) announced that the labels for all alogliptin-containing medications, including Nesina, Kazano and Oseni, would be updated with new Warnings and Precautions regarding a potential risk of heart failure. The FDA based its decision on the results of a large clinical trial, in which 3.9 percent of patients treated with alogliptin were hospitalized for heart failure, compared with 3.3 percent receiving a placebo.  Read More

Just a year earlier, a panel of FDA advisors recommended that the labeling for alogliptin medications include information about heart failure.

How Do Nesina, Kazano & Oseni Work?

Nesina (alogliptin) was approved by the U.S. Food & Drug Administration (FDA) in January 2013. It is intended to be used in conjunction with diet and exercise to control blood glucose levels in patients with Type 2 diabetes. Kazano is a combination of alogliptin and metformin hydrochloride, while Oseni contains alogliptin and pioglitazone.

Alogliptin inhibits the action of dipeptidyl peptidase-4 (DPP-4), an enzyme that removes incretin from the body. Incretin is a hormone that stimulates the pancreas to produce insulin. By inhibiting the action of DPP-4, incretin mimetics like Nesina, Kazano and Oseni, trigger the pancreas to make more insulin.

Potential Side Effects

Patients using alogliptin should check with their doctor if they experience:

• Anxiety
• Blistering, peeling, or loosening of the skin
• bloating
• Blurred vision
• Chills, cold sweats
• Coma
• Confusion
• Constipation
• Cool, pale skin
• Cough
• Dark colored urine
• Diarrhea
• Depression
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Fever
• Feeling of tiredness, weakness
• Headache
• Hives (including large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs)
• Increased hunger
• Indigestion
• Inflammation of the joints
• Itching
• Jaundice (yellowing of the skin and/or eyes)
• Joint or muscle pain
• Light colored stools
• Loss of appetite
• Nausea
• Nightmares
• Seizures
• Shakiness
• Slurred speech
• Stomach pain that is persistent
• Tightness in the chest
• Unusual tiredness or weakness
• Vomiting

The Kazano label includes a Black Box warning for lactic acidosis, a potential side effect of metformin.

Oseni includes as Black Box Warning for congestive heart failure. Bladder cancer, edema and weight gain are also potential side effects of pioglitazone.

Incretin Mimetics and Acute Pancreatitis

Nesina, Kazano and Oseni have been associated with reports of acute pancreatitis, an inflammation of the pancreas that can lead to hospitalization and death. In February 2013, researchers at Johns Hopkins University reported that patients treated with incretin mimetics were twice as likely to suffer from pancreatitis that required hospitalization.

That same year, an investigation by the British Medical Journal concluded that the pancreatic risks associated with incretin mimetics may have been downplayed by the pharmaceutical industry. The authors of the report also faulted the FDA and European regulators for failing to aggressively address these concerns. Read More

Incretin Mimetics and Pancreatic Cancer

In 2013, the FDA announced it was investigating a possible link between incretin mimetics and an increased risk of pancreatic cancer. The agency’s review was prompted by the publication of a small study that found precancerous changes in the pancreatic cells of patients who had used the medications. So far, the FDA has been unable to confirm such a link, but its review is ongoing.

Sources:

1. FDA (2013) “Nesina: Highlights of Prescribing Information” http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf
2. FDA (2013) “Kazano: Highlights of Prescribing Information” http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203414s000lbl.pdf
3. FDA (2013) “Oseni: Highlights of Prescribing Information” http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022426s000lbl.pdf
4. com (2013) “New generation of diabetes drugs raising more concerns” https://www.minnpost.com/second-opinion/2013/06/new-generation-diabetes-drugs-raising-more-concerns
5. BMJ (2013) “Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed?” http://www.bmj.com/content/346/bmj.f3680
6. FDA (2013) “FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes” http://www.fda.gov/Drugs/DrugSafety/ucm343187.htm
7. Reuters (2015) “FDA panel backs safety updates for AstraZeneca, Takeda drugs” http://www.reuters.com/article/us-astrazeneca-onglyza-fda-idUSKBN0N51U920150414