Japanese drug maker Takeda Pharmaceuticals developed the generic drug alogliptin to treat the high blood sugar levels associated with Type 2 diabetes. The brand name for alogliptin is Nesina, but the company also makes two combination drugs with alogliptin: Oseni combines it with pioglitazone and Kazano includes metformin.
Alogliptin did not come on the market until it was approved by the U.S. Food and Drug Administration (FDA), so it is considered a newcomer to the type 2 diabetes category of medicines. As a newer drug, side effects were bound to come to light and some of them have been very serious. In fact, lawsuits have already been filed by patients or their families who experienced pancreatitis, cancer, and heart failure, among other severe side effects of Nesina and other alogliptin drugs.
Alogliptin for Type 2 Diabetes
Type 2 diabetes is a condition that can have harmful and lasting health consequences if not managed, treated, and reversed. It is characterized by chronic high blood sugar and over time this can lead to nerve damage, blindness, kidney failure, and other complications. More and more people are becoming diabetic, largely because of lifestyle factors: poor diet and weight gain. Drug companies like Takeda have been pushing their type 2 diabetes drugs hard as the number of people battling it continues to grow.
Alogliptin is the new creation by Takeda to regulate blood sugar. The FDA approved it for this purpose to be used alongside healthy diet changes, exercise, and weight loss. It is in a class of drugs called DPP-4 inhibitors, which stop the action of the DPP-4 enzyme. This causes the body to then produce more insulin, the natural hormone responsible for regulating blood sugar. It also affects the liver, preventing it from producing too much sugar.
Oseni and Kazano include alogliptin along with slightly older medications pioglitazone and metformin. These two substances attack blood sugar in different ways and add to the effect of alogliptin. Combination drugs like these are designed to give a patient even greater control over blood sugar levels.
Alogliptin Side Effects
Alogliptin is a fairly new drug, which means that some of the Nesina side effects are still being discovered. According to the initial clinical trials, the most commonly reported side effects are upper respiratory infections, which cause flu-like symptoms, headaches, and joint aches. The combination forms of the drug can also cause diarrhea, urinary tract infections, high blood pressure, and back pain.
One of the more serious potential side effects of Takeda’s type 2 diabetes drugs is bladder cancer. Pioglitazone, one of the ingredients in Oseni, has been associated with this risk and it comes with the warning that anyone with a history of bladder cancer or at risk for this type of cancer should not take it.
The incidence of bladder cancer from the drug is not common, but the consequences are serious and so the FDA has warned about it. The warning says that the risk is greatest for those with a history of bladder cancer and for anyone taking pioglitazone for more than a year. The risk of bladder cancer was seen in the animal phase of clinical trials, but some studies suggest that the same risk exists for humans, even though it is not common.
Congestive Heart Failure
Pioglitazone can also increase the risk of heart failure, yet another serious side effect of these medications. Those at most risk are people who already have congestive heart failure or some of the risk factors for it. The swelling or fluid retention that the drug can sometimes cause worsens cases of existing heart failure. This means that the heart can then no longer pump efficiently and a patient is at risk of dying as a result.
Metformin, part of the Kazano combination, can cause a dangerous condition called lactic acidosis. This condition occurs when so much lactic acid builds up in the blood that the body can’t keep up with metabolizing it and it reaches dangerous levels. The risk increases for patients taking Kazano and drinking a lot of alcohol or battling an infection. Being dehydrated or having liver or kidney problems also contribute to the risk.
Pancreatic Side Effects
Many type 2 diabetes drugs, including Nesina, Oseni, and Kazano, have been found to increase the risk of both pancreatitis and pancreatic cancer. Why this happens is not fully understood, but these medications act on the pancreas to increase the output of insulin. All of these drugs come with a serious warning about pancreatitis, inflammation of the pancreas.
Most dangerous of all, alogliptin and other similar medications can cause acute or sudden onset pancreatitis. This form of the condition is life-threatening. It starts suddenly with severe pain to the abdomen and lower back, tenderness in that area when touched, and nausea and vomiting. The condition rapidly gets worse until it is considered a medical emergency. It must be treated as soon as symptoms are identified.
DPP-4 drugs like alogliptin may also increase the risk of developing the very aggressive pancreatic cancer. The main connection has been made through a study that found pre-cancerous cells in the pancreases of deceased diabetic patients. Those that had taken DPP-4 drugs had the pre-cancer cells, while those who took other types of drugs or none at all did not. The FDA has not included a warning about this risk yet, but is conducting further studies and analyzing research to find out how serious the link between the drug and the cancer is.
If you took alogliptin or any of the Takeda drugs, Nesina, Oseni, or Kazano, you may have suffered from some serious side effects. If you felt you weren’t adequately warned about the risks of those side effects, you may feel as if you have a case to sue the company for compensation. Some of these conditions could easily leave you with huge medical bills, not to mention a lot of pain and suffering. With the advice of a lawyer you can decide what to do about it next.