Prescription drugs Nesina, Kazano and Oseni are linked to serious side effects in patients, including pancreatitis, congestive heart failure, and pancreatic and bladder cancer. They contain alogliptin, which has been associated with joint pain, liver impairment and severe hypersensitivity reactions.
Nesina, Kazano and Oseni are Type 2 diabetes drugs with active ingredients linked to serious side effects.
The drugs, known as dipeptidyl peptidase-4 (DPP-4) inhibitors, all contain an active ingredient called alogliptin. Kazano also contains metformin. Oseni contains pioglitazone.
DPP-4 inhibitors, along with all three of the active ingredients found in either Nesina, Kazano or Oseni, are linked to several serious side effects and health complications, including pancreatitis, heart failure and edema (swelling associated with fluid buildup in the body), pancreatic cancer and bladder tumors.
After taking Nesina, Kazano or Oseni, people reported cases of acute pancreatitis, a condition where the pancreas becomes inflamed and swollen. In severe cases, this can lead to hospitalization and even death.
Researchers at Johns Hopkins University reported that people who took DPP-4s were twice as likely to suffer from pancreatitis that required hospitalization.
Abdominal pain associated with acute pancreatitis comes on suddenly and persists for several days. The pain becomes more constant and severe as the condition progresses.
Treatment for acute pancreatitis is carried out in a hospital, usually over a period of a few days up to a week or more. Health care providers may administer pain medicines along with intravenous (IV) fluids. Food or fluid ingested by mouth may be stopped to limit the activity of the pancreas.
Sometimes, in severe cases where vomiting and pain does not improve, a tube is inserted through the nose or mouth to remove the contents in the stomach. This procedure is called nasogastric suctioning. In the most severe cases, surgery may be needed to remove damaged, dead or infected pancreatic tissue.
Death rates are higher when the following factors are present: Hemorrhagic pancreatitis (bleeding), liver, heart or kidney impairment or necrotizing pancreatitis (when the pancreatic tissue dies).
Pancreatitis can sometimes return. Repeat episodes of acute pancreatitis can lead to chronic (long-term) pancreatitis. This type of pancreatitis does not heal or improve. Instead, it persists and worsens over time, leading to permanent damage to the organ.
Controversy still exists over whether DPP-4s can cause pancreatic cancer, and both the FDA and European Medicines Agency say that not enough evidence exists to support this link.
In one study by Alexandra Butler and colleagues published in Diabetes, the researchers examined the pancreases of organ donors who were using DPP-4s and other incretin-based therapies. Researchers found abnormal cells “with the potential for evolution into neuroendocrine tumors.”
Pancreatic cancer is difficult to detect early. Most patients have no symptoms until after the cancer has already spread. By the time the cancer has spread, a patient’s five-year survival rate drops to about one to 41 percent, depending on the location and type of cancer affecting the pancreas.
Patients with tumors that can be treated with surgery have much higher survival rates than those not treated or unable to be treated (or removed) by surgery. Treatment options depend on the stage of tumor and whether it has spread to nearby tissues, organs or lymph nodes.
Aside from surgery, other treatment options include chemotherapy and radiation therapy. These treatments may be used together in some cases, and may lead to the cancer being cured in a small number of people.
When the cancer is advanced, the primary goal of treatment is to manage the patient’s pain and other symptoms.
A 2013 study in the New England Journal of Medicine by researchers at Brigham and Women’s Hospital in Boston showed that Nesina did not increase heart attack risk. However, doctors also determined that DPP-4s may increase the risk of heart failure.
In the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial, researchers found more patients suffered congestive heart failure with Nesina than those taking a placebo. The medication insert suggests health care providers consider the risk and benefits of prescribing Nesina to patients with a history of kidney or heart failure.
In 2016, the FDA required drug makers to add a warning for heart failure to all alogliptin-containing medications.
Heart failure occurs when the heart is unable to pump enough blood to meet the body’s needs. In some cases of heart failure, the heart cannot fill with enough blood, and in other cases, the heart cannot pump blood throughout the body with enough force. Some patients may experience both problems.
The serious heart condition can affect the right side of the heart only, or it can affect both sides of the heart. Most cases involve both sides. Right-side heart failure can result in fluid buildup in the feet, ankles, legs, liver, abdomen and even the veins in the neck. When heart failure affects both the right and left side of the heart, symptoms might include shortness of breath and fatigue, or extreme tiredness.
Thiazolidinediones, including pioglitazone, an active ingredient in Oseni, have been determined to cause or worsen congestive heart failure in some patients. This occurrence is especially apparent at the initiation of drug treatment and following dose increases.
Congestive heart failure, also just called heart failure, causes blood and other bodily fluids to back up in the body, primarily affecting the liver, lungs, hands and feet.
A two-year laboratory study of the carcinogenicity (potential to cause cancer) of Oseni showed tumors in the urinary bladders of male rats. Additionally, during a three-year randomized clinical trial called PROactive, 14 patients out of a total of 2,605 participants taking pioglitazone and 5 patients out of 2,633 participants taking a placebo (dummy pill), were diagnosed with bladder cancer. This shows an almost three-times greater risk of bladder cancer in patients taking drugs containing pioglitazone, such as Oseni, compared with those who have not taken the drug.
Findings regarding the risk of bladder cancer in patients exposed to pioglitazone varied in subsequent observational studies, with some finding an increased risk of bladder cancer associated with the active ingredient in Oseni, and others finding no statistically significant increase.
Bladder cancer can often be detected early because blood in the urine called hematuria is often the first symptom, and it’s usually accompanied by other bothersome urinary symptoms as well.
When bladder cancer is found early on, the survival rate is relatively high, with stage I cancer having a five-year survival rate of nearly 90 percent. Once the cancer has spread to other parts of the body, however, it becomes much more difficult to treat with a patient’s, five-year survival rate dropping drastically to about 15 percent, according to the American Cancer Society (ACS).
Treatments for bladder cancer can include surgery, radiation therapy, chemotherapy and biologic therapy, which boosts the body’s own ability to fight off the cancer.
A patient’s overall outlook depends on certain factors that can affect their chance of recovery as well as treatment options available to them.
Nesina, Kazano and Oseni are associated with several other serious side effects and complications, some of which can lead to permanent injury or be fatal. Some of these adverse effects are linked to the class of drugs to which the diabetes medications belong to (DPP-4 drugs), or their active ingredients, including metformin (Kazano), alogliptin (Nesina, Kazano and Oseni) and pioglitazone (Oseni).
In 2016, the FDA warned that DPP-4 drugs, including Nesina, Kazano and Oseni, may cause severe and persistent joint pain. Patients who took the drugs for as little as one day suffered joint pain. Fortunately, most patients who stopped taking the drugs had relief of symptoms in less than a month.
Incidences of bone fracture have been linked to patients’ use of pioglitazone during the clinical trial PROactive (the Prospective Pioglitazone Clinical Trial in Macrovascular Events), according to drug labeling for Oseni.
In the randomized study, female patients taking pioglitazone experienced 5.1 percent of bone fractures, while female participants given a placebo (dummy pill) experienced only a 2.5 percent incidence of the same. These occurrences of bone fractures were noted after the first year of treatment and persisted throughout the course of the study.
No similar increase in bone fractures was observed in men treated with Oseni.
There have been cases of metformin-associated lactic acidosis, some of which have resulted in death. Cases of this metabolic imbalance in patients taking Kazano have come on subtly with nonspecific symptoms, such as a general feeling of sickness, muscle and abdominal pain, respiratory problems, and an increased desire for sleep.
However, some more severe cases have resulted in abnormally low body temperature, low blood pressure and certain arrhythmias (irregular heart rate) called resistant bradyarrhythmias.
Patients diagnosed with this condition require prompt hemodialysis, or the process of purifying blood in people with nonfunctional or impaired kidneys.
Fatal and nonfatal cases of liver failure have been reported in patients taking alogliptin. Some of these reports contain insufficient information to establish probable cause.
Some patients may present with elevated liver enzymes or abnormal liver tests that persist or worsen, necessitating discontinuation of the drug (Nesina, Kazano or Oseni).
Symptoms that may be indicative of injury or damage to the liver include fatigue, anorexia (self-starvation and excessive weight loss), right upper abdominal discomfort or pain, dark urine, or yellowing of the skin and whites of the eyes (jaundice).
Postmarketing reports have shown serious hypersensitivity (allergic) reactions in patients taking medications containing alogliptin, present in Nesina, Kazano and Oseni.
Please seek the advice of a medical professional before making health care decisions.
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