Abstract
Background: Identifying cancer risks associated with medicinal agents plays an important role in cancer control and prevention. Case reports of cancers associated with pharmacotherapy have been escalating in the Food and Drug Administration Adverse Event Reporting System (FAERS). The objective of this study is to assess the risk of pancreatic cancer associated with anti-diabetic drugs of dipeptidyl peptidase 4 (DPP 4) inhibitors with or without combination of metformin. Methods: Using the FAERS public database, the adverse event reports (ADRs) associated with widely used DPP 4 inhibitors with or without combination of metformin were generated and evaluated. Standardized pharmacovigilance tools were applied to detect the signal for cancer risks by calculating the proportional reporting ratio (PRR) and the reporting odds ratio (ROR). Results: Among 12618 ADRs associated with sitagliptin from 2007 to 2011, there were 223 cases of cancer. There was a significant correlation between the cancer reporting ratio and the time (R=0.796, P<0.001). Pancreatic cancers accounted for 22% of all combined cancer adverse events. Pharmacovigilance assessment from 2007 to 2012 indicated that there was a significant risk of pancreatic cancer associated with DPP 4 inhibitors treatment (ROR=5.922). Interestingly, minimal risk of pancreatic cancer risk was associated with metformin (ROR=1.214). Combination of DPP 4 inhibitor sitagliptin with metformin correlates with significantly lower risk of pancreatic cancer compared to sitagliptin treatment without metformin (OR=0.277, 95%CI: 0.210-0.365). Interpretation: There was a significant signal of pancreatic cancer risk associated with DPP 4 inhibitor treatment. For the first time we demonstrated that combination with metformin significantly reduced the risk signal of pancreatic cancer associated with DPP 4 inhibitors in FAERS. Considering the limitation of the FAERS, this study implied the potential strategy for cancer control and prevention in diabetic patients, and provided directions for future clinical studies.
Highlights
Today’s media landscape is constantly evolving toward more efficient tools of communication that can gather unprecedented amounts of information
It has the potential to serve as a whistleblower by sending alerts and alarms of drug safety signals, such as cancer risks associated with drug treatment, to the federal agencies, pharmaceutical companies, health care professionals, consumers and drug safety advocates [8]
An identified potential adverse event associated with an identified drug product for an identifiable, but anonymous, patient can be reported to the FAERS
Summary
Today’s media landscape is constantly evolving toward more efficient tools of communication that can gather unprecedented amounts of information. The new social media landscape encourages health care professionals and pharmaceutical companies to face the dilemma of engaging consumers without the fear of liability when clarifying, monitoring and reporting the adverse events [4]. This dilemma creates an important role for the government to step in and engage all the stakeholders of public health and proactively monitor and regulate the adverse events. The FAERS is a public media platform for consumers and clinicians to address their concerns of drug safety by reporting the adverse drug events to the Food and Drug Administration (FDA) [6]. The objective of this study is to assess the risk of pancreatic cancer associated with anti-diabetic drugs of dipeptidyl peptidase 4 (DPP 4) inhibitors with or without combination of metformin
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