Type 2 diabetes has reached near epic proportions in the U.S. and drug companies have answered the call for medications. Takeda Pharmaceuticals, a Japanese drug company, developed three drugs to treat this chronic condition: Nesina, Oseni, and Kazano. The all contain the generic drug alogliptin, a drug belonging to a class called dipeptidyl peptidase-4 (DPP-4) inhibitors. Nesina is the single formulation of the medication, while the other two are combinations.
Since the U.S. Food and Drug Administration (FDA) approved alogliptin in 2013 for the treatment of type 2 diabetes, numerous concerns about the drug’s possible side effects have arisen. These include lactic acidosis, congestive heart failure, pancreatitis, and pancreatic cancer and have led to Nesina lawsuits filed against Takeda.
Alogliptin and Type 2 Diabetes
Type 2 diabetes is an illness characterized by chronically high blood sugar levels. If left untreated or uncontrolled, this condition can end up causing all kinds of additional health problems like heart disease, blindness, and nerve damage. While changing to a healthier lifestyle can help combat high blood sugar, many people may benefit from the additional assistance of a medication like Nesina and its companion drugs. Most type 2 diabetes drugs have been approved to lower blood sugar but with the implication that patients will use them along with a healthy diet, exercise, and weight loss.
Alogliptin is a DPP-4 inhibitor, which means that it stops the action of the DPP-4 enzyme. DPP-4 is involved in the metabolism of sugar and by blocking it alogliptin increases the amount of insulin in the blood, the hormone that regulates blood sugar. It also prevents some of the sugar from food entering the bloodstream, especially right after a meal.
Oseni contains alogliptin as well as pioglitazone, a thiazolidinedione that helps the body become more sensitive to insulin. Kazano includes alogliptin with metformin, a biguanide drug that slows how much sugar is absorbed from food. These two combination drugs can help drop blood sugar levels even more dramatically than alogliptin alone.
As with any medication alogliptin comes with potential side effects. For most people these are mild and not serious. They include headaches, infections, joint pain and gastrointestinal issues. Fewer patients will experience more serious side effects, but if they do they may be life-threatening. Heart failure is one of these and it is these more serious complications that have led to Oseni, Kazano, and Nesina lawsuits.
Oseni, because of the proglitazone, has been found to increase the risk of congestive heart failure, a dangerous condition in which the heart does not pump blood as well as it should. The root of the problem is edema, also known as swelling from fluid retention. This can significantly worsen existing heart failure.
Pancreatitis and Pancreatic Cancer
All three of the Takeda drugs have also been connected to risk of pancreatitis, inflammation in the pancreas, and potentially pancreatic cancer. The labels for the drugs state that there is a risk of acute pancreatitis, a version of the illness that sets in suddenly and gets severe quickly. This can be fatal if not treated. It is also very painful and debilitating.
More evidence is also coming out that shows alogliptin could increase the risk of pancreatic cancer in some patients. Pancreatitis can lead to cancer, but the drug may also independently put patients at risk of cancer. The FDA is still waiting on more evidence to issue an official warning, but those who have already suffered from this type of cancer after taking type 2 diabetes believe any warning is already late.
Metformin, one of the ingredients in Kazano, is known to potentially cause lactic acidosis, a dangerous condition. The labeling for the drug includes a black box warning, the FDA’s strongest warning, about the risk. Lactic acidosis occurs when too much lactic acid builds up in the blood. Without treatment it can quickly become fatal. There are warnings about this condition, but some people have suffered from lactic acidosis and don’t believe they got adequate warning about the risk. Takeda may end up facing lawsuits from patients who ended up with this condition.
Alogliptin is still very new and more and more information about its risks is always coming to light. Bladder cancer is one of these possible risks that is currently under investigation. There is already some evidence to connect several type 2 diabetes drugs to bladder cancer. The evidence is strongest against proglitazone and the FDA has already made an official statement about it. The agency has warned that anyone with a history of bladder cancer should not be taking this medication. It is also known that the risk increases especially after one year on the drug.
Many of the people who took any of Takeda’s type 2 diabetes drugs have suffered some of the serious complications that they can cause. Plaintiffs in these cases hope for justice to be served and for the company to pay punitive damages as well as compensation or their own expenses and losses. They accuse the company of failing to warn the public, patients and doctors about the potential risks of using their drugs. They also say that the company was negligent in contributing to their illnesses, and that they made and promoted, marketed, and sold a defective medical product.
Takeda’s products are still fairly new and have only been on the market since 2013. Resolutions to lawsuits may not come for a few more years, but in the meantime it is likely that more will be started. Other companies with similar drugs have already faced numerous lawsuits and have had to pay out in settlements. Many of these cases have focused on pancreatitis and pancreatic cancer. While the drug companies continue to deny any negligence, these patients are making the case that they would not have suffered these devastating illnesses if it weren’t for the diabetes medications.
If you have been harmed by Takeda’s Nesina, Kazano, or Oseni, you still have time to get a lawsuit in that could bring you the compensation you need to get your life back together. A lawyer can help you get started and help you decide what your options are