The concern is over the potential for Januvia pancreatic cancer, a very serious illness for which there is no cure. Most pancreatic cancer patients are dead within a year. Various observational studies have found no increased risk of pancreatic cancer amongst users of incretin mimetic drugs, a class to which Januvia belongs.However, a recent study, according to the Herald Tribune report, found that risk for acute pancreatitis doubled. And Dr. Peter C. Butler, chief of endocrinology, diabetes and hypertension at the University of California has done his own studies, the outcomes for which have been a cause for worry.
Butler was originally invited by Januvia manufacturer Merck to test its drug on rats - to determine if incretin mimetics could rid diabetic rats of Type 2 diabetes. Merck agreed to fund the study, Butler told the Herald Tribune. But he declined the offer initially.
When he later agreed to do the Januvia side effects study, Dr. Butler was concerned by what he found; what were described as worrisome changes in the pancreases of the rats under study, changes that could lead to Januvia pancreatic cancer.
Both the US Food and Drug Administration (FDA) and the European Medicines Agency took notice, and are continuing their own investigations.
Butler’s critics view the data as inconclusive, with Dr. Robert E. Ratner, chief scientific and medical officer with the American Diabetes Association, stating that were excess risk even a factor at all, it would remain “exceptionally low.”
However, Butler, who is also the former editor of Diabetes, the journal of the American Diabetes Association, also has his defenders. Butler himself notes that studies undertaken prior to the approval of incretins by the FDA tended to involve younger, healthier animals that might not be expected to emerge with pancreatic cancer.
What’s more, any patient or potential plaintiff concerned about the potential for Januvia cancer would be interested in Butler’s latter study of human pancreases obtained, according to the report, from 34 organ donors having died due to circumstances unrelated to disease of the pancreas.
Eight of the donors were taking incretins, and Butler found pancreases of those eight people tended to have more precancerous lesions than the organs of the diabetics who had not taken those drugs, or those of the non-diabetics. There was also one case of a neuroendocrine tumor, a type of pancreatic cancer, amongst the pancreases inherent with the incretin users. Also, the pancreases of the incretin drug users presented as heavier with faster growth of certain cells.
Seven of the eight incretin donors had been taking Januvia.
Butler’s study on human pancreases also has its detractors, including Dr. Fred Gorelock, a professor of medicine and cell biology at Yale, who noted the precancerous lesions found had been early-stage ones. Many middle-age people have these, and they often do not lead to cancer.
Still, Gorelock said, the study “raised several red flags,” according to comments published in the Herald Tribune.
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Patients concerned about the potential for Januvia pancreatitis might be well advised to pay close attention to information due for release later this summer, according to the Herald Tribune report. Results from randomized clinical trials studying any potential association between incretins and heart issues will also likely reveal any increased risk of pancreatitis. The National Institutes of Health is meeting next month to also study the association between diabetes, diabetes drugs and pancreatic cancers.
For patients taking Januvia, and worried about Januvia and pancreatitis, such information will be welcome and potentially revealing. Little wonder, given the virtual death sentence that pancreatic cancer represents, that a call may go out to a Januvia lawyer.