Lack of Information About Link Between Byetta, Victoza, Januvia and Pancreatic Cancer

Austin Kirk

By Austin Kirk
Posted June 17, 2013


In recent years, as doctors have continued to switch diabetic patients to a new class of diabetes drugs, which includes the blockbuster medications Januvia, Victoza and Byetta, increasing evidence has emerged suggesting a link between use of the drugs and an increased risk of pancreatic cancer. However, serious concerns exist about the lack of research conducted by the drug makers and the failure to provide adequate information about the potential risk for consumers and the medical community.

Earlier this year, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) both announced that they were investigating the risk of pancreatitis and pancreatic cancer from Januvia, Janumet, Vitoza, Byetta and other diabetes medications that are part of a broad class of new drugs known as incretin mimetics.

This action and at least three published reports have increased concerns among consumers and the medical community about the safety of these new medications:

  • February 2013: An independent analysis of health insurance data found that when compared to diabetes patients using other medications, users of Januvia and Byetta were at double the risk of developing pancreatitis, which involves inflammation of the pancreas that may ultimately lead to the development of pancreatic cancer.
  • April 2013: An analysis of adverse event reports submitted to the FDA found an increasing number of reports involving pancreatitis and pancreatic cancer among users of Januvia, Janumet, Byetta and Victoza when compared to those taking diabetes drugs that are not part of the incretin mimetic family.
  • March 2013: An analysis of changes to the pancreas of organ donors exposed to incretin mimetics demonstrated pre-cancerous and dyplastic changes, which is a strong signal that the drugs may cause pancreatic cancer.

According to allegations raised in Januvia lawsuits, Janumet lawsuits, Byetta lawsuits and Victoza lawsuits being filed on behalf of individuals throughout the United States diagnosed with pancreatic cancer, the manufacturers of these medications have known or should have known about the risks associated with their drugs, yet failed to adequately research the potential side effects or warn about the potential risks.

An editorial published this month in the British Medical Journal (BMJ) highlights the emerging evidence about a link between Byetta, Victoza, Januvia and pancreatic cancer, asking the question of why patients and doctors have not been told?

“The BMJ has found that, despite published reports that indicated safety concerns, companies have not done critical safety studies; nor have regulators requested them. And access to raw data that would have helped resolve doubts about the safety of these drugs has been denied.”

The manufacturers of Byetta, Januvia, Janumet and Victoza have defended the safety of their drugs, maintaining that individual pieces of evidence are inconclusive on the risk. However, as the BMJ editorial points out, when the unpublished evidence is considered together with other evidence and data, a troublesome picture about the safety of these drugs emerges.

“While the debate continues about pathophysiology and mechanism of action, questions remain about whether the companies and regulators have done enough to get to the bottom of these safety concerns. And have doctors and patients been adequately warned?”

The editorial comes the same week the American Diabetes Association (ADA) called on all drug companies selling incretin mimetic medications to make patient-level data on their products available for an independent review to help settle the questions about the link between Byetta, Victoza, Januvia and pancreatic cancer.

If information surrounding the potential risk of pancreatic cancer were provided, users and doctors would be in a position to make an informed decision about whether the potential benefits of the medications justify the risks. In addition, if information about the potential concerns had been provided earlier, doctors and patients could have monitored for the first signs of changes to the pancreas, which may have helped those suffering chronic asymptomatic pancreatitis from ultimately developing pancreatic cancer from Januvia, Byetta and Victoza.

The pancreatic cancer lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals throughout the country who may be entitled to financial compensation as a result of the drug makers’ failure to adequately research the side effects of Byetta, Victoza and Januvia or warn about the potential risk of pancreatic cancer.

To review a case for yourself, a friend or family member request a free consultation and claim evaluation.

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