What is Januvia?

Sitagliptin is the drug found in Januvia which reduces blood sugar levels in patients with type 2 diabetes. Sitagliptin inhibits the DPP-4 enzymes in the body which destroy GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent isnsulinotropic polypeptide). The effect of GLP-1 and GIP are to reduce blood glucose levels so when sitagliptin inhibits the enzyme that destroys them, blood glucose levels fall. After a meal, incretin hormones are released from the intestine, increasing their levels in the bloodstream. Januvia, when combined with diet and exercise, can improve blood glucose levels in those with type 2 diabetes and is combined I some cases with other types of oral drugs for diabetes such as Janumet which combines sitagliptin with metformin.

Research has found that Januvia may cause pancreatic abnormalities which can in turn lead to pancreatitis, and, ultimately, to pancreatic cancer. It is believed that Januvia’s ability to spur the production of the cells lining the pancreatic ducts can sometimes lead serious medical issues. In short, Januvia has been found to cause abnormalities in the pancreas that are recognized as risk factors in the development of pancreatitis, and, in time, pancreatic cancer.

According to a recent Bloomberg report, Januvia, sold by Merck & Co., may double the patient’s risk of developing inflammation of the pancreas. When the pancreas becomes inflamed, cancer and kidney failure may occur. Patients who were hospitalized due to pancreatitis were twice as likely to be taking a diabetic drug containing sitagliptin—like Januvia—than diabetics without pancreatitis according to a journal article in the JAMA Internal Medicine. The FDA issues an alert for Januvia in 2009 based in part on one study which analyzed data from 2005 to 2008 showing that the number of pancreatitis cases had more than doubled. While Januvia does appear to do well in regulating blood sugar, patients should carefully weigh the risks against the benefits.

Allergic reactions are always a possibility with any prescription drug and Januvia is no different. Patients who have difficulty breathing, hives or swelling of the face, lips, tongue or throat after taking Januvia should seek emergency medical help immediately. Some of the more common, less serious, side effects of Januvia include runny or stuffy nose, sore throat, nausea, stomach pain, diarrhea, constipation, joint or muscle pain, back pain and headache. More serious side effects include pancreatitis—a severe pain in the upper stomach which spreads to the back along with vomiting and nausea—infrequent urination, a red or purple skin rash which causes blistering and peeling (Stevens-Johnson syndrome), weight gain with swelling and shortness of breath. Hypoglycemia has been reported by some patients as well as upper respiratory tract infections, worsening renal function or renal failure and musculoskeletal pain.

When cancerous cells develop in the tissue of the pancreas, pancreatic cancer—a rapidly spreading cancer that is rarely discovered in the beginning stages—can develop. A diagnosis of pancreatic cancer comes with a very poor prognosis. Approximately 45,000 Americans are diagnosed with pancreatic cancer each year, and only about 3% of those will survive five years past the diagnosis. Signs of pancreatic cancer include jaundice, loss of appetite and weight loss, upper abdominal pain which radiates to the back, depression and blood clots. A study published in Gastroenterology tied the use of Januvia to an increased risk of pancreatic cancer; researchers noted that patients taking Januvia had 2.7 times the risk of pancreatic cancer as those who were not taking the drug. Because Januvia stimulates the pancreas to produce more insulin, the pancreas gland can become inflamed, leading to the risk of pancreatic cancer.

The thyroid can be adversely affected by the medication in Januvia as it affects the glucagon-like-peptide-1 (GLP-1), increasing the number of precancerous thyroid cells in rats. Although still serious, thyroid cancer has a much better prognosis than pancreatic cancer. The 2011 journal article in Gastroenterology also noted that Januvia had been linked to thyroid cancer however this is still under investigation. Thyroid cancer is relatively rare, however those taking Januvia should be aware of the symptoms of thyroid cancer such as a lump or nodule in the front center part of the neck, hoarseness, pain in the neck and throat, swallowing problems, cough, enlarged lymph nodes, itching and diarrhea. Researchers from the University of California determined that Januvia could increase the risk of thyroid cancer 148% and pancreatic cancer by 270%.

Although Merck has continued to maintain that Januvia is a safe drug, a number of lawsuits have been filed against the company from patients who suffered adverse health effects from Januvia. According to FDA data there were hundreds of reports of acute and chronic pancreatitis attributed to Januvia in 2011. The lawsuits which have been filed most all claim that Merck & Co. failed to warn patients of the dangers and risks they were exposing themselves to when they began taking Januvia even though Merck was aware of adverse reports from patients taking the drug. Between October, 2006 and February, 2009, the FDA received 88 reports of acute pancreatitis; in over half these cases the patient’s pancreatitis resolved once Januvia was discontinued.

Although the FDA has issued warnings to health care providers and consumers regarding the potential risks of Januvia there has been no recall of the drug. Consumers were advised in 2009 and 2013 that Januvia had been linked to pancreatitis and pancreatic cancer. While the FDA required additional label warnings, there were no restrictions on its use. The FDA directed Merck to conduct new studies regarding the potential risks of Januvia and was forced to issue a notice of violation of that order in February, 2012, because Merck delayed the testing. Your Januvia attorney can keep you apprised of any new information regarding Januvia, particularly should a recall be issued in the future.

If you or a loved one has suffered damages from the drug Januvia, it is important that you speak with a knowledgeable attorney who fully understands every aspect of this drug. A Sullo & Sullo attorney will discuss the specifics surrounding your use of Januvia, taking into consideration the extent of your injuries. Together you will determine whether a lawsuit against Januvia is warranted. Your Sullo & Sullo lawyer will ensure you understand all the steps in filing such a lawsuit and will offer professionalism and compassion while fighting aggressively for your rights and your future.

Your specific Januvia damages will depend largely on the extent of your injuries. If you or a loved one developed potentially deadly pancreatic cancer as a result of taking Januvia for your type 2 diabetes then your damages could be extensive. Medical expenses, lost wages—both past, present and future—and pain and suffering may all be a part of your claim. If you suffered an attack of pancreatitis but did not develop pancreatic cancer from Januvia, then your damages may not be as high, however you still may be entitled to compensation.

Your potential Januvia case may be protected by speaking with an experienced Sullo & Sullo attorney. Our attorneys are well aware of the statute of limitations regarding defective drug cases and can help to make sure that time limit is not exceeded. Regardless of the extent of injury you have received from taking Januvia, our highly skilled attorneys will fight aggressively to protect your case and will file your claim in a timely manner.

The statute of limitations for defective drugs or medical devices differs from state to state. Most states, such as Texas, operate under a two-year statute while some have a three-year limit and a handful have time limits of four or more years. In defective drug cases, the time when the statute begins can be rather fuzzy. If there was a recall issued for the drug, the statute likely begins at that time. In some cases companies claim that a warning they issued was sufficient notice and the time of that warning is when the statute should begin. In any case, should you discover the statute in your state has expired, speak to a Sullo & Sullo attorney before you give up—there are certain instances in which the statute may be extended.

Like many big drug companies, Merck & Co. may very well blame the adverse health effects suffered by Januvia users on other factors in their life. For instance, it is more common for diabetics to develop pancreatitis than for non-diabetics therefore Merck may attempt to say any side effects are simply the effect of the diabetes, rather than the drug. Any pre-existing health issues suffered by Januvia users might be used against them to deny a settlement. For this reason it is imperative that you consider the knowledge and experience of the attorney you choose.

Each attorney at Sullo & Sullo, LLP fully understands that every case is different. We treat each client as an individual, offering exceptional personal attention and compassion. Our reputation is outstanding in the industry and we are zealous advocates for every single client. If you have been harmed by Januvia—or any other harmful drug or defective medical device—strongly consider speaking to a Sullo & Sullo Januvia lawyer today to get the help you need.