Januvia

Januvia (generic name sitagliptin), is prescribed by doctors to treat type 2 diabetes. It promises to control high blood sugar – a serious condition that can lead to kidney damage, blindness, nerve problems, loss of limbs and sexual function problems.

Januvia tablets are a DPP-4 inhibitor, and work by upping levels of incretins, which release insulin and decrease sugar made by the liver. Another drug, Janumet, is similar, but combines Januvia with metformin for better glycemic control.

The drug has numerous listed side effects, some of them serious, and the U.S. Food and Drug Administration has investigated reports of pancreatitis and pre-cancerous cells in the pancreas by those using Januvia or Janumet. Also included in this class of drugs are Byetta and (exenatide) and Victoza (liraglutide).

At The James Esparza Law Group, our Januvia injury lawyers in Salt Lake City, Utah are reviewing potential claims involving adverse side effects from Januvia and Janumet – specifically those risks about which manufacturer Merck & Co. allegedly failed to warn.

The FDA approved Januvia in 2006 and Janumet in 2007 (the latter with a with the most severe “black box warning” for risk lactic acidosis, since it is made with metformin). Both Januvia and Janumet are top-selling brands in their class, with 2 million prescriptions and annual sales reportedly exceeding $6 billion in recent years.

The U.S. Centers for Disease Control and Prevention reports nearly 100 million Americans have diabetes or prediabetes (with 30 million having diabetes). Our product liability attorneys firmly believe no one should be placed unknowingly at risk of a serious illness or death simply for seeking to manage diabetes – something several plaintiffs in Januvia lawsuits are alleging.

Problems with Januvia

As it stands, there are an estimated 6,000 pending lawsuits consolidated in a multi-district litigation action in a federal court in Chicago against AndroGel maker AbbVie. An MDL is a means to consolidate cases in federal court to avoid conflicting schedules and discovery duplication.

Prior to FDA approval, an initial clinical trial of 5,200 participants over the age of 55 did confirm Januvia and Janumet reduced blood sugar, with common side effects including colds, respiratory tract infections and headaches.

The rarer, but more serious, side effects listed by the manufacturer include:

• Allergic reactions (difficulty breathing, hives, swelling of face, lips, throat or tongue);
• Kidney problems requiring dialysis;
• Bullous pemphigoid, a skin reaction that can require hospital treatment;
• Unusually fast weight increase.

After federal approval, several independent studies were conducted, and the results troublingly indicated the potential for serious health risks that were not listed.

Regulators received some 200 reports of pancreatitis (some instances deadly) in 2011 alone.

In 2012, the FDA ordered Merck to test whether Januvia and Janumet could possibly raise the risk of an inflamed pancreas (pancreatitis), which can be deadly if it goes untreated. Merck promised to follow through with a three-month analysis, but failed, resulting in an FDA warning that the product was misbranded because the pharmaceutical firm was in violation of post-marketing requirements.

In 2013, the FDA issued a Drug Safety Communication regarding Januvia/ sitagliptin, promising to evaluate unpublished physician findings indicating an heightened risk of pancreatitis and pre-cancerous cellular changes (called pancreatic duct metaplasia) in patients with type 2 diabetes who were taking Januvia. The FDA had not reached any conclusions about the drug’s safety risks but did remind the public of early reports of serious and fatal pancreatitis cases by Januvia users.

Soon after, researchers with the JAMA Internal Medicine journal (published monthly by the American Medical Association) specifically looked at the risk of acute pancreatitis (which has high fatality rates) for those taking Januvia. Participants ranged in age from 18 to 64 during February 2005 to December 2008. Researchers concluded use of the drug “significantly increased the odds of acute pancreatitis” requiring hospitalizations.

Later in 2013, the FDA denied cause for concern regarding pancreatitis – however noted that its own reviews were still ongoing. In a report released the following year, published in the New England Journal of Medicine, both the FDA and the European Medicines Agency (EMA) indicated they had not reached a definitive conclusion about the causal relationship between Januvia and pancreatitis or pancreatic cancer.

Then in 2016, a study published in the European Journal of Clinical Investigation indicated users of Januvia/ sitagliptin were at “significantly higher risk” of developing pancreatic cancer compared to non-users, particularly when they were consuming a higher cumulative dose of the drug. Researchers suggested lower doses were appropriate and future studies would be necessary.

Merck now also lists potential side effects as including:

• Pancreatitis (a swelling of the pancreas resulting in vomiting, increased heart rate, nausea, stomach pain and back pain which can be severe and even lead to death);
• Severe joint pain (as noted in this FDA Drug Safety Communication).

There is still no mention of the potential for developing cancer.

Contact the Salt Lake City Januvia injury attorneys at the James Esparza Law Group by calling toll-free 800-745-4050.