June 12, 2013 — The British Medical Journal has published an editorial after an investigation unearthed concerns about a link between diabetes drugs and pancreatic cancer.
A new class of type-2 diabetes drugs, called incretin mimetics (Januvia, Byetta, Victoza, and more) work by influencing hormones that reduce blood-sugar levels. Unfortunately, studies have found that these hormones can also inflame the pancreas (causing acute pancreatitis) and stimulate the proliferation of cells in the pancreas — two major risk-factors for pancreatic cancer.
The authors cited three major studies published this year linking incretin mimetic drugs to pancreatic cancer. One study, published in February, found that people taking Januvia (sitagliptin) and Byetta (exenatide) were twice as likely to be hospitalized for acute pancreatitis compared to people taking other anti-diabetic drugs. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have confirmed increased signals of pancreatic cancer, but Merck and Bristol-Myers Squibb deny a causal relationship.
Even some experts say that the evidence linking diabetes drugs and pancreatic cancer is weak — mostly because pancreatic cancer is rare, many of these drugs are new, and manufacturers have not completed adequate safety studies. However, despite the lack of adequate studies, there could still be a serious risk.
For example, in a rodent study published in 2007, twelve rodents with diabetes who were given Januvia (sitagliptin) developed enlarged pancreases, one developed acute pancreatitis, and three out of 16 developed cellular changes thought to be a precursor to pancreatic cancer. In other studies, the pancreases of mice given Byetta increased in weight, suggesting proliferation of cells.
Several studies have also evaluated the FDA adverse event database. One paper, published by researchers from UCLA and published in Gastroenterology in 2012, presented data from 2004 to 2009. They found a 6-fold increase in cases of pancreatitis associated with Byetta, a 3-fold increase in reports of pancreatic cancer, and a 4-fold increase in thyroid cancer. Although researchers admitted the methodology of the study was limited, other independent studies have corroborated the UCLA team’s findings.
The investigators were also concerned about a study published in Diabetes earlier this year, in which a team of researchers analyzed the pancreases of human organ donors. They found the pancreases of patients who had been taking an incretin mimetic were 40% larger than normal. Several had pre-cancerous cell growths called adenomas and one had a small neuroendocrine tumor.
The FDA and drug manufacturers continue to deny a causal relationship between incretin mimetic diabetes drugs and pancreatic cancer. As the debate continues, many lawyers and experts are concerned that doctors and patients are not being fully informed of the risk.
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