Nesina, Oseni, and Kazano are type 2 diabetes medications made by Japanese drug manufacturer Takeda Pharmaceuticals. All three contain the same generic drug, alogliptin, but Oseni and Kazano are combinations and include an additional medication. The U.S. Food and Drug Administration (FDA) approved these three medications in 2013 for use in adults with type 2 diabetes who are also making lifestyle changes.
These three Takeda drugs are relatively new to the market. In particular, alogliptin is a new substance. As people have begun to use the drugs, new concerns have arisen that they can cause serious side effects in some patients. These include congestive heart failure, pancreatitis, pancreatic cancer, and a very serious condition called lactic acidosis. Lawsuits have already been filed against Takeda by those who have suffered from one or more of these side effects.
Nesina, Oseni, Kazano and Type 2 Diabetes
These medications are indicated for the treatment of type 2 diabetes in adults. They are not supposed to be used in people with type 1 diabetes or to treat a condition known as diabetic ketoacidosis. Type 2 diabetes is a condition in which a person stops producing enough insulin or has become insensitive to it. Insulin is a hormone produced in the pancreas that is released in response to high blood sugar.
Without enough insulin, or sensitivity to it, a person is at risk of having chronically high blood sugar levels, which can lead to type 2 diabetes. Long-term effects of having this kind of diabetes include heart disease, nerve damage, and eye damage, among many others. With a healthier diet, exercise, and weight loss, this type of diabetes can be reversed. Using medications like Nesina, Oseni, and Kazano along with these lifestyle changes helps many people to better control blood sugar levels.
How They Work
Each of the three medications contains a new drug created by Takeda, called alogliptin. It belongs to a class of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. These drugs work by stopping the action of the enzyme called DPP-4, which is involved in the metabolism of glucose, or sugar, in the blood. By inhibiting DPP-4, alogliptin increases the amount of insulin that the pancreas makes and releases into the bloodstream. It also stops the liver from contributing more sugar to the bloodstream, particularly right after eating.
Oseni includes both alogliptin and another drug called pioglitazone, which belongs to the thiazolidinediones class of medications. These act to make the body more sensitive to insulin. As a combination of these two medications, Oseni works to both decrease sugar in the blood and to make insulin more effective.
Kazano contains a combination of alogliptin and metformin. Metformin is a type of drug called a biguanide. The drugs in this class reduce blood sugar by reducing how much glucose the body absorbs from food and by slowing how much glucose is made in the liver. It also helps to make the body more sensitive to insulin. As with Oseni, this combination attacks the problem of high blood sugar from several fronts.
Side Effects
Naseni, Oseni, and Kazano have been proven to be effective at controlling blood sugar, but they also may cause side effects. The most commonly reported side effects from Naseni are upper respiratory infections with flu- and cold-like symptoms, headaches, and joint pain. Kazano also may cause upper respiratory infections and symptoms, but also diarrhea and other gastrointestinal symptoms, urinary tract infections, headaches, back pain, and high blood pressure. For Oseni, the most common side effects are upper respiratory infections and back pain.
Pancreatitis and Pancreatic Cancer
While these three medications were only approved in 2013, other type 2 diabetes drugs that are similar were found to increase the risk for pancreatitis and pancreatic cancer, both of which can be life-threatening. All three of the drugs come with a warning that they may cause acute pancreatitis. This is a sudden-onset form of the condition—inflammation of the pancreas—and can be deadly if not treated right away.
Post-marketing studies found reports of acute pancreatitis and the warning states that if there are any signs of the condition, use should be discontinued immediately. These signs include sudden and serious pain in the upper middle and upper left side of the abdomen that may radiate to the back. The pain is most likely to come on or worsen after eating. The pain will become constant and gets worse. Anyone experiencing these signs should get emergency medical attention.
Chronic pancreatitis may lead to pancreatic cancer, but there is also some evidence that DPP-4 drugs like alogliptin could increase the risk of developing this type of cancer. The FDA has not yet issued any warnings about it as it states that the evidence is not yet strong enough.
Bladder Cancer
An increased risk of developing bladder cancer has been associated with pioglitazone, one of the ingredients in Oseni. The indications for this drug suggest that it should not be used in anyone with bladder cancer or with a history of bladder cancer. The FDA has issued a warning regarding the use of pioglitazone and the risk of bladder cancer. It states that anyone who has used the medication for a year or more may be at an increased risk, although it is still rare.
Lactic Acidosis
Kazano carries a black box warning, the FDA’s strongest warning reserved for the most serious and life-threatening risks of taking a medication. The warning for Kazano is of the risk of lactic acidosis. The warning states that the risk of developing this serious condition increases in anyone who drinks alcohol excessively, has an infection, has liver or kidney damage, or is dehydrated.
Metformin is the ingredient in Kazano that may cause lactic acidosis. The condition is characterized by a buildup of lactic acid in the blood and can be deadly if not treated right away. Signs of lactic acidosis include fatigue and weakness, general discomfort, vomiting, nausea, loss of appetite, stomach pains, shortness of breath, a changed heartbeat, lightheadedness, and muscle pain.
Heart Failure
Proglitazone, one of the ingredients in Oseni is known to increase the risk of congestive heart failure in people taking it. It causes fluid retention in the body, which in turn causes edema or selling, weight gain, and potentially heart failure. Edema worsens existing heart conditions and interferes with the ability of the heart to pump blood. This is congestive heart failure, and it is fatal if not treated.
Anyone with congestive heart failure is not supposed to take Oseni. Patients already taking it who experience swelling in the ankles and legs, trouble breathing and shortness of breath while lying down, fast weight gain, and fatigue, should be treated right away as these are signs of heart failure.
Lawsuits
Because of all the potentially serious side effects that are possible from taking Naseni, Oseni, and Kazano, lawsuits have been filed against the manufacturer. In particular, suits have been filed by patients or on behalf of patients who developed pancreatic cancer while taking one of these medications. While there are no warnings against the risk, some people claim that the drugs did cause their cancer and that the drug company should be held accountable.
With other issues possible, like heart failure, bladder cancer, and lactic acidosis, future lawsuits against Takeda may be filed. If you have taken any of these drugs and been among the unfortunate few to suffer a serious illness as a result, you have time to consult with a lawyer and file a lawsuit to seek damages for your suffering.
Sources
- https://www.nlm.nih.gov/medlineplus/druginfo/meds/a699016.html
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- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm336942.htm
- http://general.takedapharm.com/content/file.aspx?FileTypeCode=KAZANOPI&cacheRandomizer=6d067b50-f4a5-4aac-ba71-3d1cddd79afe
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4c619ed9-fe3e-4158-9938-80c6c3493d55
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