FDA Further Researching Type 2 Diabetes Drug, Januvia, Pancreatic Cancer Links

Date Published:

Approved in 2006 by the U.S. Food & Drug Administration (FDA), the Type 2 diabetes medication, Januvia, continues to be associated with risks for pancreatic side effects that include pancreatic cancer.

In 2009, the agency required a label update warning of the risk of acute pancreatitis, a painful, potentially fatal disorder and a known risk factor for pancreatic cancer.

Icretin mimetics, drugs such as Januvia (sitagliptin), have been the subject of research, including unpublished new findings that are being evaluated by the U.S. Food and Drug Administration (FDA). This research was conducted by a group of academic researchers whose findings suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes—pancreatic duct metaplasia—in Type 2 diabetic patients treated with incretin mimetics.

Findings were based on a review of a small number of pancreatic tissue specimens taken from patients who died from a number of causes. The agency has since asked the researchers to provide the methodology used to collect and study these specimens, as well as with the tissue samples utilized so that it may continue investigating potential pancreatic toxicity associated with Januvia and other incretin mimetics.

Other drugs in the incretin mimetic class that are made with the same active ingredient as Januvia include Janumet, Janumet XR, and Juvisync. Incretin mimetics imitate the body’s incretin hormones, which are meant to stimulate insulin release following a meal.

Januvia Whistleblower Protection Under the False Claims Act

In recent years, many pharmaceutical employees have come forward to report fraudulent billing, illegal marketing techniques and undisclosed drug side effects.

Although the FDA said it has not reached any new conclusions about the safety risks associated with Januvia and similar drugs, the agency informed the public and the health care community that it intends to secure and evaluate the new information that reveals links between these Type 2 mediations and increased risks for pancreatic diseases, including cancer of the pancreas. The FDA previously issued a warning concerning post-marketing reports of acute pancreatitis—fatal and nonfatal—associated with sitagliptin, known by its brand name, Januvia, and exenatide. The agency has not advised the public about the pre-cancerous cell changes seen with these drugs, The Associated Press (AP) noted; however, in a notice on its website, said Reuters, the FDA indicated that this is the first time it has communicated a possible pre-cancerous link to incretin mimetics.

Prior research revealed that Januvia (sitagliptin) has been associated with reports of increased risks for pancreatic and thyroid cancers. In fact, researchers at the University of California, Los Angeles looked at Type 2 diabetes drugs, including Januvia, in comparison to other therapies and all of the drugs’ risks for pancreatic and thyroid cancers and pancreatitis. The study revealed that Januvia patients experienced a nearly three-fold risk of developing pancreatic cancer.

The False Claims Act allows for private persons to file lawsuits providing the government with information about wrongdoing. Under the Act, if a person is found to have knowingly submitted or caused others to submit false or fraudulent claims to the U.S., the government may recover treble damages and $5,500-$11,000 per statute violation. Should the government be successful in resolving or litigating its claims, the whistleblower can receive 15-25 percent of recovered recovered. Should the government decline to join the case, the lawsuit may proceed privately; the whistleblower will be entitled to a 25-30 percent recovery reward in this case.

Companies are prohibited from retaliating against a whistleblower, under the False Claims Act. In fact, an employee who is discharged, demoted, suspended, threatened, or harassed for filing a whistleblower lawsuit can bring an action for re-instatement with his/her seniority restored, recovery of double back pay with interest, and other compensatory damages. Whistleblowers may initially and anonymously report fraud by filing a claim through an attorney. The whistleblower’s identity remains under seal while the Justice Department investigates the case. Should the government choose not to pursue the case, the firm will never know the whistleblower’s identity, unless the claim is privately pursued.