In 2006, Merck & Co. (Merck) was approved by the U.S. Food and Drug Administration (FDA) to market Januvia (sitagliptin), a top selling medication used by millions of patients and the first in a new class of diabetes medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. The drugs are used to lower blood sugar in adults with Type 2 diabetes, the most common form of the medical condition where the body does not use insulin properly causing blood glucose (sugar) levels to rise higher than normal.
The drugs work by slowing the metabolism of naturally-occurring hormones known as incretins, specifically Glucagon-Like Peptide-1 (GLP-1). Diabetics typically do not produce enough of these hormones and this type of drug allows these hormones to be active in the bloodstream longer to reduce blood sugar levels. Januvia, and similar drugs Byetta and Victoza, increase GLP-1 receptor activity in a patient by mimicking incretin hormones that stimulate the release of insulin in the body (especially after a meal) and decreasing the amount of sugar made by the liver.
Since approving incretin mimetic drugs, the FDA has issued warnings to health care professionals linking the drugs to a “potentially serious adverse drug event” in patients after receiving 88 reports of acute pancreatitis between 2006 and 2009. Pancreatitis has been associated with serious complications, including infection, kidney failure and pancreatic cancer in patients with long-term inflammation. In 2011, the FDA threatened to sanction Merck for failing to complete a proposed animal study on pancreatitis risk associated with Januvia by June 2011, as required by the FDA in its 2006 approval. Merck is reported to have then submitted results of an independent study to the FDA, which the FDA rejected and in February 2012, required Merck to submit a new proposal and begin the study within six months. As of September 2015, Merck has not released any pancreatitis study results. In March 2013, the FDA commenced an investigation into possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs.
Multiple lawsuits are pending in state and federal courts against Merck claiming Januvia is a defective drug that increases a patient’s risk of pancreatic. The complaints allege that Merck:
knew Janvuia could pose a risk of pancreatic cancer and withheld information from doctors and patients;
failed to provide adequate warnings on Januvia and included no reference to pancreatic cancer;
failed to advise doctors to monitor Januvia users for pancreatic changes;
continues to promote Januvia as a safe and effective drug;
failed to perform adequate safety tests of Januvia; and
aggressively promoted Januvia without appropriate warnings about its risks.
The suits seek damages for lost income, diminishment of earning capacity, medical bills and pain and suffering.
In 2013, the U.S. Judicial Panel on Multidistrict Litigation approved a motion to consolidate all federal cases involving Januvia and similar diabetes drugs in the U.S. District Court for the Southern District of California (MDL 2452) before Judge Anthony J. Battaglia.
Article Type: Lawsuit
Topic: Patient Care