Relationship between SGLT2 inhibitor use and risk of lower limb amputations: a pharmacovigilance study

Abstract

Type 2 Diabetes Mellitus is a chronic, complicated, multifactorial condition affecting millions of people worldwide. A variety of anti-diabetic pharmacological interventions are available for the condition. Amongst many such drugs, SGLT2 inhibitors have multiple benefits such as reno-protection, weight loss, and reduced hypertension. However, some harmful adverse effects also exist that need to be addressed and monitored to ensure patient safety. For instance, these drugs are suspected to be linked to an increased risk of limb amputations, although findings from previous studies remain inconclusive. The current study therefore collected post- marketing data from the FAERS database to establish or disprove a significant association between use of SGLT2 inhibitors and increased risk of limb amputations.