Merck & Co. developed and manufactures the type 2 diabetes medications Januvia and Janument. They were approved for use in treating the condition by the U.S. Food and Drug Administration (FDA) in 2006 and 2007, respectively. While Januvia is a single-combination medication, Janumet is a combination of two: the Januvia plus a second drug. Both are popular prescriptions for treating type 2 diabetes along with changes in diet and exercise.
Although both Januvia and Janumet have been proven to be effective in lowering blood sugar in type 2 diabetes patients, Merck may not have adequately warned patients and doctors of some of the more serious risks of taking it. These include such serious conditions as pancreatitis, pancreatic cancer, and thyroid cancer. If you have been taking one of these medications and believe they may have contributed to your cancer or pancreatitis, you may be able to file a successful lawsuit against Merck.
Januvia and Janumet for Type 2 Diabetes
Type 2 diabetes is a condition that is characterized by blood glucose, or sugar, levels that are too high. In someone without diabetes, the pancreas releases a hormone called insulin when sugar levels get high. This hormone triggers a process that brings glucose levels back down to a healthy amount. If you have type 2 diabetes, either your pancreas is not providing enough insulin, or your body is not as sensitive to insulin as it should be. In either case having chronically high blood sugar levels is harmful and causes complications like eye problems, nerve damage, and heart disease.
Eating a healthier diet, losing weight, and exercising more can all help slow or reverse the course of type 2 diabetes, but with complications so serious doctors may prescribe a blood sugar-lowering medication to accompany lifestyle changes. There are several different types of drugs that doctors may prescribe, including Januvia, which is a drug called sitagliptin, or Janument, a combination of sitagliptin and a drug called metformin.
How They Work
Sitagliptin, or Januvia, is a drug that belongs to a class of medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by inhibiting DPP-4, an enzyme that plays an important role in the metabolism of glucose. When sitagliptin inhibits DPP-4 it causes two actions that help to lower blood sugar: it increases the amount of insulin secreted by the pancreas and it prevents the liver from adding more sugar to the bloodstream, especially after a meal.
Janumet targets high blood sugar in two ways. First it includes sitagliptin, which has the above effects on insulin and glucose. It also contains a second medication called metformin. This drug is often used first in patients to treat type-2 diabetes, especially those that are overweight or obese. It belongs to a class of medications called biguanides and has several effects on blood glucose. It reduces the amount of sugar the body absorbs from food, prevents the liver from making too much glucose, and it makes the body more sensitive to insulin.
As with most medications, Januvia and Janumet come with side effects. The most common side effects of Januvia include upper respiratory tract infections, nasopharyngitis, headaches, diarrhea, joint pain, and hypoglycemia, or low blood sugar. Januvia has also caused severe allergic reactions in some patients. Signs of this life-threatening condition include swelling in the face, mouth, and throat, a rash and hives, and trouble breathing and swallowing. If you experience these symptoms, get emergency medical treatment.
Janumet’s most common side effects are similar to those seen with Januvia. They include upper respiratory tract infections, diarrhea, gas and bloating, muscle pain, indegiestion, and headaches. Although it is not that common, a very serious possible side effect of taking Janumet is lactic acidosis. This occurs when lactic acid builds up in the body faster than it can be metabolized and removed.
Lactic acidosis can be life-threatening if not treated. Warning signs are weakness, extreme tiredness, nausea and vomiting, a decreased appetite, shortness of breath or rapid breathing, dizziness, feeling cold, muscle pain, and a slow or fast heartbeat. Anyone on Janumet experiencing these symptoms should get immediate medical attention. A severe allergic reaction, like that sometimes seen with Januvia, is also possible.
Pancreatitis and Pancreatic Cancer
Sitagliptin, which is in both Januvia and Janumet, has been linked to an increased risk of pancreatitis and pancreatic cancer, both very serious conditions. This includes acute pancreatitis, which may come on suddenly and be fatal. Anyone taking either of these drugs should be aware of the signs of pancreatitis and seek emergency treatment. The signs of sudden, or acute, pancreatitis include abdominal pain that radiates to the back, abdominal pain that gets worse after eating, tenderness when the abdomen is touched, vomiting, and nausea.
The FDA received almost 100 reports of acute pancreatitis related to Januvia after the medication had been approved. In 2009 the FDA issued a warning of this risk. The warning included the fact that pancreatitis can develop into pancreatic cancer. In 2013 the FDA announced that it would continue the investigation to determine how great the risk really is and to further study how Januvia and Janumet are connected to a risk for pancreatic cancer.
In addition to the risk to the pancreas, reports have been made that there may be an increased risk of developing thyroid cancer while on Januvia or Janumet. Research on this is slim, but studies have found a slightly increased risk. These studies find that the risk is higher with other type 2 diabetes drugs. Signs of thyroid cancer include neck pain and swelling, changes in the voice, coughing, hoarseness, and difficulty breathing and swallowing.
Several lawsuits have been filed against Merck by people who have developed cancer, acute pancreatitis, and other health problems after taking Januvia or Janumet. Many of the people filing these suits claim that Merck did not take adequate steps to warn patients or doctors of the small, but very real risk of developing serious and life threatening conditions like thyroid cancer, pancreatic cancer, and acute pancreatitis.
In one unfortunate situation, a federal judge throughout several suits against Merck and other companies. The judge ruled in this way because he said that the FDA would not allow the drug companies to put pancreatic cancer on the drug labels as a possible risk. The companies, including Merck, then charged the cancer patients who had sued them for their legal fees.
And yet the evidence continues to accumulate. Most recently the FDA’s adverse events reporting database showed that there seemed to be a ten-fold increased risk in developing pancreatic cancer for people using Januvia or Janumet. That makes pancreatic cancer still rare, but it is life-threatening and many believe it warrants a stronger warning on drug packaging.
The fight is far from over and if you or a loved one has suffered because of taking Januvia or Janumet, you can join the battle against Merck. Lawsuits will continue to go forward and more evidence comes to light. It just may show that Merck knew about the risks of cancer and did nothing to slow their marketing of these drugs or warn patients. Seek the advice of a lawyer to get started and you may be on the front line of winning back damages from a drug company giant.