Background: Recently, Food and Drug Administration (FDA) has approved Dulaglutide (GLP-1 analog) for the treatment of type 2 diabetes mellitus. However, regarding Adverse Drug Reactions (ADRs) of Dulaglutide in a large group of population, very less information is available. Thus, in the present investigation, we tried to find out the risk and benefit profile of Dulaglutide.
Materials and Methods: The data related to risk and benefit profile of Dulaglutide has been extracted from various sources like Pub-Med, Regulatory Websites of various agencies, Clinical trial registry etc. from Sep 2014 (first approval) to Feb 2018. A total of 182 studies have been published from Sep 2014 to Feb 2018 regarding Dulaglutide. After inclusion and exclusion criteria, 25 studies have been selected for risk and benefit analysis.
Results: The results of the current study have shown the various therapeutic benefits of Dulaglutide (reduces weight, decreases progression of nephropathy, reduces incidence of myocardial infarction, reduces blood pressure etc.) in the treatment of type 2 diabetes mellitus. However, emerging evidence has also indicated the various risks associated with Dulaglutide such as septicemia, malignant neoplasm, coronary artery disease and pancreatic cancer.
Conclusion: In conclusion, Marketing Authorization Holder (MAH) and Regulatory Authorities (RAs) should consider these safety issues in future.
Keywords: Adverse Drug Reaction (ADRs), benefits, diabetes mellitus, GLP-1 analog, dulaglutide, regulatory authorities.