The odds of suffering from a symptom that signals the onset of pancreatitis or pancreatic cancer are multiples higher when the patient is exposed to Januvia (sitagliptin) and to drugs in its class in comparison to exposure to a different class of diabetes-treatment medications.
As Januvia lawsuits still may be filed, and indeed are being filed, such is a result of the nonprofit Institute for Safe Medical Practices' surveillance of 1,723 adverse events that were reported to the U.S. Food and Drug Administration between July 1, 2011, and June 30, 2012.
The study, released in 2013, generated odds ratios for the emergence of signals for pancreatitis, pancreatic cancer and other conditions that surfaced in those who used "glucagon-like peptide-1 based therapies," such as Januvia, and in those who used a drug control group comprised of other kinds of diabetes therapies. Januvia, an oral medication, was in a class that included injectable drugs Byetta (exenatide) and Victoza (liraglutide) as well as oral drugs Onglyza (saxagliptin) and Tradjenta (linagliptin).
"An odds ratio is a measure of association between an exposure and an outcome," reads an article published in the August 2010 edition of the Journal of the Canadian Academy of Child and Adolescent Psychiatry. "The OR represents the odds that an outcome will occur given a particular exposure, compared to the odds of the outcome occurring in the absence of that exposure."
The institute observed, according to its own April safety alert, that the odds of suffering from the signals of pancreatitis were 28.5 times higher in the injectable-drug group in comparison to the odds of developing those conditions after using a control-group drug. The oral-drug outcome nails Januvia. Although the oral medication odds were 20.8 times higher as a whole, the highest individual odds ratio was for sitagliptin, or generic Januvia.
As for suffering from the signals of pancreatic cancer between the two categories of medications, those who took the injectable drugs experienced 23.3 times higher odds. Although the oral-medication odds were 13.5 percent higher as a whole, sitagliptin separated from the other two oral drugs because "both linagliptin and saxagliptin had just a single reported case each, with an increased OR that was not statistically significant."
In litigation, there are no guarantees. Nevertheless, clearly, those who have used Januvia and who since have been diagnosed with a pancreatic disorder may be entitled to compensation that can be awarded or settled in a Januvia lawsuit. If this study is not convincing, then look at how prevailing science previously forced the FDA's hand.
The U.S. Food and Drug Administration in September 2009 announced that it would revise "the prescribing information for Januvia and Janumet to include information on reported cases of acute pancreatitis in patients using these products."
Further, the FDA announced in March that the agency has been "evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics," a group that includes sitagliptin.
Januvia lacked an adequate warning of its association with an increased risk of pancreatic disorders from its 2006 approval until its 2009 FDA-initiated safety labeling changes. Januvia's maker, Merck, should have known about the unreasonable risks that its product posed, and the manufacturer should have taken precautionary steps in the interest of public health before millions were unwittingly exposed to those risks.
Dozens of Januvia lawsuits and actions related to other incretin mimetics have been filed in numerous U.S. jurisdictions. Attorneys, including the Januvia lawyers at Reich & Binstock, are investigating hundreds of additional cases to determine whether the patients are entitled to compensation. Reich & Binstock reaches out to the victims at no cost to them. The attorney consultation is free.
Pancreatic cancer and pancreatitis are serious disorders that require extensive medical monitoring. These illnesses induce pain and suffering. Plaintiffs in Januvia lawsuits can attest to that as they and their counsel pursue justice and hold Merck accountable.
The manufacturer is a part of the problem; Reich & Binstock can be a part of the solution. To learn at no charge whether you or someone you know has a viable case for a Januvia lawsuit, contact the law firm, which operates in every state, either toll-free at 1-866-LAW-2400 or online by submitting the electronic case evaluation request form posted on this website.