FDA and EMA say incretin-based antidiabetics do not cause pancreatitis and pancreatic cancer
News - Mar. 3, 2014
U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) together state in a perspective in the New England Journal of Medicine of February 27 that recently expressed assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer are inconsistent with the current data.
Drugs that act as incretin receptor agonists (e.g. exenatide) or that inhibit the proteolytic degradation of incretins (e.g., sitagliptin) have been approved by both agencies, based on clinical data establishing efficacy in improving glycaemic control.
The FDA and EMA reviewed nonclinical toxicology studies, clinical trial data, and epidemiologic data pertaining to blood glucose–lowering drug products (e.g. exenatide and sitagliptin) that stimulate postprandial insulin release by potentiating the incretin hormone pathways, in reaction to concerns about post-marketing reports of pancreatitis and pancreatic cancer in patients taking these antidiabetic medication.
The agencies independently undertook comprehensive evaluations of pancreatic safety of these agents, thereby assessing the evidence of reported adverse events, while considering factors that might confound safety analysis in the context of antidiabetic drugs.
The FDA and EMA conclude, based on all available evidence and types of data, that the data do not support a causal relationship between incretin-based drugs and pancreatitis or pancreatic cancer, as was recently expressed in scientific literature and in the media.
The FDA and EMA do not reach a final conclusion with regard to such a causal relationship, since they will continue to investigate this safety signal. Although the currently available data is reassuring, pancreatitis will continue to be considered a risk associated with these drugs until more data are available.
The FDA and EMA believe that the current insights are adequately reflected in the product information or labelling.
Source
Egan AG, Blind E, Dunder K et al., Pancreatic Safety of Incretin-Based Drugs — FDA and EMA Assessment. N Engl J Med 2014; 370:794-797
Find this perspective online
U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) together state in a perspective in the New England Journal of Medicine of February 27 that recently expressed assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer are inconsistent with the current data.
Drugs that act as incretin receptor agonists (e.g. exenatide) or that inhibit the proteolytic degradation of incretins (e.g., sitagliptin) have been approved by both agencies, based on clinical data establishing efficacy in improving glycaemic control.
The FDA and EMA reviewed nonclinical toxicology studies, clinical trial data, and epidemiologic data pertaining to blood glucose–lowering drug products (e.g. exenatide and sitagliptin) that stimulate postprandial insulin release by potentiating the incretin hormone pathways, in reaction to concerns about post-marketing reports of pancreatitis and pancreatic cancer in patients taking these antidiabetic medication.
The agencies independently undertook comprehensive evaluations of pancreatic safety of these agents, thereby assessing the evidence of reported adverse events, while considering factors that might confound safety analysis in the context of antidiabetic drugs.
The FDA and EMA conclude, based on all available evidence and types of data, that the data do not support a causal relationship between incretin-based drugs and pancreatitis or pancreatic cancer, as was recently expressed in scientific literature and in the media.
The FDA and EMA do not reach a final conclusion with regard to such a causal relationship, since they will continue to investigate this safety signal. Although the currently available data is reassuring, pancreatitis will continue to be considered a risk associated with these drugs until more data are available.
The FDA and EMA believe that the current insights are adequately reflected in the product information or labelling.
Source
Egan AG, Blind E, Dunder K et al., Pancreatic Safety of Incretin-Based Drugs — FDA and EMA Assessment. N Engl J Med 2014; 370:794-797
Find this perspective online
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