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Curr Drug Saf. 2019;14(2):87-93. doi: 10.2174/1574886314666190206164647.

Safety of SGLT2 Inhibitors in Patients with Diabetes Mellitus.

Current drug safety

Mahakpreet Singh, Ruchika Sharma, Anoop Kumar

Affiliations

  1. Department of Pharmacy Practice, Indo-Soviet Friendship Pharmacy College (ISFCP), Moga, Punjab, India.
  2. Department of Biotechnology, Indo-Soviet Friendship Institute of Professional Studies (ISFIPS), Moga, Punjab, India.
  3. Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPERRaebareli), Lucknow, UP, India.

PMID: 30727912 DOI: 10.2174/1574886314666190206164647

Abstract

BACKGROUND: Recently, Food and Drug Administration (FDA) has approved sodium/ glucose co-transporter 2 (SGLT2) inhibitors for the treatment of diabetes mellitus. However, regarding adverse drug reactions (ADRs) of SGLT2 inhibitors in large group of population, very less information is available. Thus, we have tried to find out the risk profile of SGLT2 inhibitors.

MATERIALS AND METHODS: A total of 1,042 studies have been published from Nov. 2012-Nov. 2017 regarding SGLT2 inhibitors. After inclusion and exclusion criteria, 27 studies have been selected for the analysis of risk.

RESULTS AND DISCUSSION: The emerging evidence indicates various adverse drug reactions such as foot and toe amputation, cancer, diabetic ketoacidosis, bone fracture risk and urinary as well as mycotic genital infection. The causality assessment has shown a correlation between SGLT2 inhibitors and diabetic ketoacidosis and urinary tract infection.

CONCLUSION: In conclusion, Marketing Authorization Holder (MAH) and Regulatory Authorities (RA) should monitor various adverse drug reactions such as diabetic ketoacidosis and urinary tract infection with the use of SGLT2 inhibitor.

Copyright© Bentham Science Publishers; For any queries, please email at [email protected].

Keywords: ADRs; SGLT2 inhibitors; anti-diabetic drugs; diabetes mellitus; metabolic disorders; risks.

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