Diabetes in America

As with many drugs and medical devices recently in the news for adverse effects, the risks from the diabetic drug Januvia are believed to be significant. Over 300 million people across the globe suffer from diabetes, about 30 million of those in the United States. In fact, diabetes is the fifth leading cause of death in the United States. The global market for drugs which treat diabetes is over $41 billion dollars—a figure that is expected to increase to $114 billion within the next five years.

Januvia, manufactured by Merck & Co, showed annual sales in 2011 of $3.3 billion dollars. When combined with its sister drug, Janumet, that number reached $4.7 billion in 2011. The Januvia diabetic drug—also sold in a combination pill with metformin, called Janumet—was developed as a means of controlling blood sugar in those patients with type 2 diabetes when used in combination with diet and exercise. Januvia works by targeting the natural body system to help regulate glucose by affecting the pancreatic beta and alpha cells in the pancreas.

Januvia inhibits an enzyme known as DPP-4 (dipeptidyl peptidase-4) which is produced in the gut following a meal and is responsible for breaking down incretins—hormones which tell the pancreas to produce more insulin and tell the liver to stop producing blood sugar. When DPP-4 is inhibited, the amount of incretins rises, causing the body to produce more insulin and reduce blood-sugar.

The medication found in Januvia and Janumet—Sitagliptin—has been linked to acute pancreatitis, pancreatic cancers and other serious medical issues. Januvia safety problems surfaced relatively soon after the drug was marketed. Januvia gained FDA approval in October, 2006, and by February, 2009, had received 88 post-marketing cases of acute pancreatitis. Of those 88 patients, 19 developed pancreatitis within 30 days of when they began taking Januvia.

A study published in the medical journal, Gastroenterology, in 2011 definitively linked the use of Januvia with an increased risk of pancreatic cancer and pancreatitis. Researchers found that Januvia and Janumet patients had six times the increased risk of pancreatitis and 2.7 times the risk of pancreatic cancer. Results from a smaller study of organs from diabetic patients treated with Januvia showed an increase in beta cell mass and pancreatic mass which potentially increases the risks of developing pancreatic cancer. A more recent study, reported in JAMA Internal Medicine in February, 2013, showed those taking Januvia had approximately double the rate of developing acute pancreatitis.

Symptoms of acute pancreatitis include severe abdominal or back pain accompanied by nausea, vomiting, tenderness or swelling of the stomach, fever and chills. Researchers analyzed insurance records and found that patients hospitalized with pancreatitis were twice as likely to be using Januvia as compared to diabetics who did not develop pancreatitis. The risk of Januvia pancreatitis is believed to be roughly double among patients taking the drug and because of this, the FDA flagged pancreatitis cases among Januvia patients in 2009. Dr. Edwin A. M. Gale, professor of diabetes medicine in England commented on recent Januvia data published in the British Medical Journal stating that we should be very worried about the link between Januvia and pancreatitis as “All forms of pancreatitis, clinical or subclinical predispose to carcinoma of the pancreas.” Dr. Gale categorized the number of reports of pancreatitis associated with Januvia and other similar diabetic drugs as reaching “astronomical proportions.”

Pancreatic cancer is the fourth leading cause of cancer death for both men and women and is considered one of the deadliest types of cancer. Nearly 45,000 Americans will be diagnosed with pancreatic cancer each year and 38,000 will die from it. The pancreas is a fairly large organ located in front of the spine and behind the stomach. The function of the pancreas is to make insulin which regulates blood sugar levels and to make enzymes which are released into the intestines to aid the body in absorbing fats as well as breaking up proteins and carbohydrates.

Pancreatic cancer is difficult to diagnose, and, unfortunately, it is often diagnosed late in the course of the disease. Early detection can significantly increase a person’s chance of survival. Those who have taken Januvia should be on the alert for any unexplained weight loss, dark urine, back pain, jaundice or clay-colored stools. Any of these symptoms should be taken very seriously and an appointment with a physician made immediately to discuss Januvia pancreatic cancer.

Although the development of Januvia liver problems is still being investigated among those using the drug for type-2 diabetes, anecdotal evidence suggests Januvia may indeed have a negative effect on the liver for certain patients. Specifically, any individual with a history of non-alcoholic steatohepatitis (a type of liver disease characterized by inflammation of the liver with concurrent fat accumulation in the liver) or elevated haptic enzymes, might have a propensity for liver problems with Januvia.

One case study presented in The Annals of Pharmacotherapy detailed a 58-year old male with a history of type 2 diabetes and non-alcoholic steatohepatitis who developed elevated hepatic enzyme levels soon after starting Januvia. In the course of a full medication review it was determined that Januvia was the most likely cause of the increased liver enzymes and the drug was discontinued. Tests of the liver enzymes a month after discontinuing Januvia showed a significant decrease in liver enzymes and by six months an even greater decrease.

Some research indicates that those people with multiple sclerosis, rheumatoid arthritis, high blood pressure or osteoporosis—in addition to type 2 diabetes—are at a higher risk of developing thyroid cancer while taking Januvia. A study published in Gastroenterology in 2011, linked Januvia to at least two cases of thyroid cancer. While most people who develop thyroid cancer will survive, like pancreatic cancer it must be detected early. The first symptoms of thyroid cancer are often a lump in the front, center region of the neck, difficulty breathing, frequent coughing, neck or throat pain, difficulty swallowing and changes to the voice such as hoarseness. Treatment can include radiation, chemotherapy and lifelong hormonal supplements should the thyroid gland require removal.

Other Januvia diabetic drug dangers include severe allergic reactions, persistent sore throat, red, blistered or peeling skin and a serious, sometimes fatal condition, known as lactic acidosis. Lactic acidosis causes lactic acid to build up dangerously in the bloodstream at a faster rate than the body can remove it. Most of the lactic acidosis cases have occurred in those diabetic patients who also suffer from kidney or liver problems or heart disease. Risks of lactic acidosis escalate among patients who drink alcohol or are elderly. Other potential side effects from Januvia include nausea, appetite loss, vomiting, headache, abdominal pain, sore throat, upset stomach, diarrhea, upper respiratory infection and runny or stuffy nose.

Those who have suffered harm as a direct result of taking a drug they believed to be safe should consider speaking with a knowledgeable Januvia attorney such as those at the Law Firm of Sullo & Sullo, LLP. The highly experienced attorneys of Sullo & Sullo understand the devastation an unsafe drug or medical device can cause, turning patient’s lives upside down. We fight hard for our clients, taking a personal interest in each client and never thinking of them simply as a “case.” We are legal professionals who will discuss the specific details of your adverse health issues from taking Januvia, then communicate your options clearly and compassionately. Call Sullo & Sullo, LLP today for the help you need.