Januvia, a drug which is used in the treatment of type 2 diabetes—along with diet and exercise—has recently come under fire for its potential risks from consumers and from the FDA. Type 2 diabetes affects how the body metabolizes sugar; the body is either resistant to insulin or fails to manufacture sufficient levels of insulin. Januvia is a relatively new class of drugs known as sitagliptin which inhibits or blocks dipeptidyl peptidase-4 (DPP-4). By blocking DPP-4 the body is able to better control levels of glucose in the body, increasing the levels of insulin produced by the pancreas when blood sugars are at their highest levels. When the body does not need excess sugar, the DPP-4 blockers can help can lower that amount.

Januvia issues began surfacing fairly soon after the drug gained FDA approval in 2006. Accounts of severe allergic reactions as well as the occurrence of Stevens - Johnson syndrome – a skin condition which has caused fatalities in some instances—surfaced soon after Januvia was marketed. By 2009, 88 reports of acute pancreatitis had been received by the FDA, with 19 of those patients developing pancreatitis within 30 days of starting Januvia. Acute pancreatitis involves unexpected swelling of the pancreas and can be very serious or even life-threatening. Symptoms of pancreatitis include abdominal pain which worsens after eating, abdominal pain which radiates to the back, nausea, vomiting and tenderness of the abdomen. Januvia problems continued to grow; the FDA issued a warning to healthcare professionals in 2009 and again in 2012 although they have stopped short of a recall.

The FDA has Januvia safety concerns due to the high number of patients who have developed acute pancreatitis while taking Januvia. More than half of the patients who developed pancreatitis required hospitalization, while four ended up in intensive care. More than 50% of these patients resolved their pancreatitis soon after they stopped taking Januvia. A recent UCLA study found users of Januvia had six times the risk of pancreatitis and were 2.7 times more likely to develop pancreatic cancer. These Januvia dangers have led to a significant number of Januvia lawsuits from those harmed by the drug although a recall has not yet been issued. Pancreatic cancer is the fourth leading cause of all cancer deaths and is rarely diagnosed until it is in the latter stages. In addition to pancreatitis and pancreatic cancer, at least one study suggests an increase in thyroid cancer among Januvia users as well.

It seems that perhaps Merck & Co. failed to warn consumers and physicians regarding the potential Januvia dangers. It is likely that claims against Merck will allege product liability and negligence as well as failure to warn. In the end this failure to warn could relate to financial gain: in 2011 the annual sales for Januvia rose nearly 40% to $3.3 billion dollars. Combined with its sister drug, Janumet (a combination of Januvia and metformin) sales reached $4.7 billion for 2011. Those who believe they should pursue Januvia legal action should take care to speak to a reputable attorney who will carefully evaluate the specific facts and determine whether a Januvia lawsuit is in the best interests of the patient. Sullo & Sullo attorneys have spent many years helping victims of harmful drugs and defective medical devices. We advocate tirelessly for our clients, working hard to ensure they receive a fair settlement for their injuries. If you have been injured by Januvia—a drug you were likely told was perfectly safe—we want to speak with you about your options and your future.