Eli Lilly and Boehringer Ingelheim collaborated to make the two drugs, Tradjenta and Jentadueto, which are used to treat type 2 diabetes. This condition is characterized by dangerously high blood sugar levels and these two medications work to lower blood sugar and prevent patients from suffering serious complications of diabetes. Tradjenta was approved by the U.S. Food and Drug Administration in 2011 and Jentadueto not long after that.
Evidence from clinical trials and research to show that Tradjenta and Jentadueto are effective at lowering blood sugar levels in people with type 2 diabetes, but there are some issues. It has also been found that these medications may raise the risk of developing pancreatitis, a serious and life-threatening condition, and even pancreatic cancer. Lawsuits have already been filed against Boehringer Ingelheim, which makes a similar type 2 diabetes medication, and which may cause pancreatitis, so it may not be long before Eli Lilly faces the same kinds of lawsuits.
How Tradjenta and Jentadueto Are Used
Tradjenta is the generic drug called linagliptin and Jentadueto is a combination of linagliptin and another drug used to lower blood sugar, called metformin. While a single type 2 diabetes drug can lower blood sugar, it has been found that combining more than one of these drugs can have an even more dramatic effect.
Both medications are approved by the FDA to treat the high blood sugar levels seen in patients with type 2 diabetes. They are not approved to be used for people with type 1 diabetes, sometimes called juvenile diabetes, and they cannot treat diabetic ketoacidosis. Tradjenta and Jentadueto are supposed to be prescribed to be used together with lifestyle changes, like eating a better diet and getting more exercise.
When the high blood sugar levels associated with type 2 diabetes are not lowered, serious complications can result. These include stroke, heart attack, nerve pain and damage, vision problems, gum disease, and kidney failure. Lifestyle changes can help lower blood sugar and reduce the risk of these complications, but adding a blood sugar-lowering medication helps to get levels lower faster.
How They Work
Both Tradjenta and Jentadueto treat type 2 diabetes by lowering blood sugar, or blood glucose, levels. In a healthy person, the pancreas makes and excretes a hormone called insulin in response to high blood sugar levels. The body responds to the release of insulin by lowering blood glucose. This process keeps blood sugar levels steady over time. If you have type 2 diabetes, either your pancreas has stopped making enough insulin or your body has become less sensitive to it. Either way, the results is chronically high blood glucose levels.
Linagliptin is a type of medication called a dipeptidyl peptidase-4 (DPP-4) inhibitor. It inhibits, or blocks the action of an enzyme called DPP-4, which is responsible for breaking down the hormones that lead to the excretion of insulin from the pancreas. By blocking this enzyme, linagliptin leads to higher levels of insulin, and lowered blood sugar levels.
Jentadueto contains both linagliptin and metformin, a type of drug called a biguanide. Biguanides also lower blood sugar, but in a different way from DPP-4 inhibitors. These drugs reduce how much sugar the body absorbs from food and helps make the body more sensitive to insulin. Both effects lower blood glucose levels. By attacking blood sugar levels from multiple fronts, Jentadueto has the ability to lower blood sugar more quickly than a single medication.
Both Tradjenta and Jentadueto have been proven to be effective at lowering blood sugar in people with type 2 diabetes, but like most medications they also cause some side effects. These have to be weighed against the benefits of using the drugs to decide if they are worth taking. Fortunately for most people who use these medications, there are only a few common side effects and they are not often serious or severe.
With Tradjenta and Jentadueto, possible side effects include cold-like infections, which cause symptoms like a stuffy nose, a cough, or a sore throat. They may also cause diarrhea, headaches, and joint pain. Another possible risk with either drug is hypoglycemia, or dangerously low blood sugar levels. This is more likely to happen if you take more than one drug that lowers blood glucose levels. Signs of hypoglycemia include headaches, sleepiness, dizziness, confusion, sweating, hunger, irritability, weakness, a fast heartbeat, and a jittery feeling.
Although rare, it is also possible that some people will experience a serious allergic reaction when taking Tradjenta or Jentadueto. Signs of this severe reaction, called anaphylaxis, include swelling in the face, mouth, and throat, difficulty swallowing, difficulty breathing, hives, and an itchy rash. This needs to be treated as a medical emergency and is fatal if not treated right away.
Metformin, the second ingredient in Jentadueto, may cause a serious side effect called lactic acidosis. This is a buildup of lactic acid in the body, which occurs faster than the substance can be metabolized. It is dangerous and may be fatal if not treated immediately. Signs of lactic acidosis that should be taken seriously include a decreased appetite, nausea, vomiting, weakness, fatigue, rapid breathing, shortness of breath, muscle pain, a feeling of coldness, and a heartbeat that is too slow or too fast.
One of the biggest concerns with taking linagliptin is the possibility of developing pancreatitis, inflammation in the pancreas. Pancreatitis is a serious condition, but even worse is acute pancreatitis, a form of the condition that starts suddenly, is severe, and is deadly if not treated immediately. Tradjenta and Jentadueto come with a warning about pancreatitis, but some people believe the waring should be stronger.
Signs of acute pancreatitis include a sudden onset of symptoms like pain in the abdomen that radiates to the back, nausea, vomiting, a fever, and a rapid heart rate. The pain experienced in pancreatitis gets worse after eating and when bending forward. It only gets worse with time. It will not get better.
People taking linagliptin may also be at an increased risk of developing pancreatic cancer. Other DPP-4 inhibitors have been found to increase this risk by as much as two times. The risk has been found to be increased the longer a person takes one of these medications. Pancreatic cancer is one of the deadliest of all cancers. It is hard to detect and is often only found when it is too late to treat effectively.
The FDA issued a warning about the risk of pancreatic cancer with DPP-4 inhibitors in 2013. The warning stated that evidence for the risk of pancreatitis is strong, but that more research is needed to determine just how risky these drugs are for the development of cancer. The evidence came from some patients taking these drugs who were found to have pre-cancerous cells in the pancreas. The evidence is not conclusive according to the FDA, but strong enough to warn patients and doctors.
Diabetes drugs are big money for pharmaceutical companies like Eli Lilly and Boehringer Ingelheim, which teamed up to bring Tradjenta and Jentadueto to market. These two drug makers have profited from their new diabetes drugs, but they also may share the costs of future lawsuits. While the evidence on the risk of pancreatic cancer is still shaky, it is strong for pancreatitis and people have died from this condition.
Lawsuits have been filed against the companies that make other, similar drugs for type 2 diabetes, and Tradjenta and Jentadueto may be next in line. People who felt they were not adequately warned of the risk have filed lawsuits looking for the compensation they need to recover. If you have been affected by linagliptin, you also may have a strong case against Ely Lilly and Boehringer Ingelheim.