New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Pancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based Therapies GASTROENTEROLOGY 2011;141:150–156 • “In conclusion, analysis of the FDA adverse event reporting database suggests that the GLP-1 class of drugs being widely promoted for treatment of type 2 diabetes could have serious unintended and unpredicted side effects.” • “Pancreatitis is 6-fold more likely to be reported in association with sitagliptin or exenatide than other therapy” • “We have a concern that there is a significantly increased association of thyroid cancer and pancreatic cancer with these therapies.” • “The most obvious conclusion from these studies is that careful long-term monitoring of patients treated with GLP-1 mimetics or DPP-4 inhibitors is required.” Pancreatitis, Pancreatic, and Thyroid Cancer With Glucagon-Like Peptide-1–Based Therapies GASTROENTEROLOGY 2011;141:150–156 • “For now this analysis of the FDA data base does not establish that pancreatitis, pancreatic and thyroid cancer are caused by GLP-1based therapy. It simply raises the level of concern that they may be and that the appropriate prospective studies are required to rule them out.” Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 GLP-1–Based Therapies: The Dilemma of Uncertainty Gastroenterology 2011; 141:20-23 • The accompanying editorial states “…more reliable studies must be performed. Until then, the questions about the potential link between GLP-1–based therapies and pancreatitis and tumorigenesis remain open. The fact that GLP-1–based therapies have no record of lowering clinical endpoints (ie, mortality, stroke, myocardial infarction) does not inspire confidence and more informative prospective randomized trials with such patient-relevant clinical endpoints are urgently required.” • “For the sake of patients, history will hopefully not repeat itself in the case of GLP-1–based drugs. Two thoughts remain: primum non nocere and “vigilance equals avoidance.” Dabigatran- Pradaxa by Boehringer Ingelheim Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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