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Byetta Lawsuit - Claims Move Forward, as Panel Considers Consolidation of Federal Claims Involving Byetta and Similar Diabetes Drugs, Bernstein Liebhard LLP Reports
Date:7/26/2013

ll of the Byetta lawsuits filed thus far allege the drug’s manufacturers concealed the association between Byetta and pancreatic cancer, and failed to provide adequate warnings regarding its risks.

Over the past several months, the entire class of incretin mimetics, including Byetta, have been the subject of mounting safety concerns, amid a growing body of evidence that indicates they could have harmful effects on the pancreas. In 2008, for example, the U.S. Food & Drug Administration (FDA) issued a Byetta pancreatitis warning after receiving a high number of reports of the disorder in users of the drug.* In February 2011, research published in Gastroenterology suggested a risk of pancreatic cancer among Byetta users, reporting that the drug appeared to increase the likelihood for the disease by nearly 3-fold. The same study also reported 30 cases of thyroid cancer and a six-fold increase risk for pancreatitis among Byetta users.**

In February 2013, a paper published in JAMA Internal Medicine reported that drugs like Byetta appeared to double the risk for pancreatitis.*** On March 14, the U.S. Food & Drug Administration (FDA) announced it was investigating findings from an unpublished study that suggested Byetta and other incretin mimetics could be associated with pre-cancerous cellular changes in the pancreas called pancreatic duct metaplasia.**** Then in April, the Institute for Safe Medicine Practices (ISMP) published an analysis of FDA adverse event reports that revealed incretin mimetics were 25 times more likely to be linked to pancreatic cancer compared to other diabetes drugs. During a 12 month period that ended in June 2012, the ISMP tallied 263 reports of pancreatitis, 71 instances of pancreatic cancer, and 14 cases of thyroid cancer among Byetta users.***** Most recently, a review of regulatory data conducted by the British Medical Journal revealed unpublished data pointing to “unwanted proliferative or inflammatory pancreatic ef
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4. Pancreatic Cancer Correlation to Type 2 Diabetes Drugs Januvia and Byetta, New Studies Find Possible Connection
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