Using real-world safety data in regulatory approval decisions: Sotagliflozin and the risk of diabetic ketoacidosis

Pharmacoepidemiol Drug Saf. 2020 Oct;29(10):1322-1324. doi: 10.1002/pds.4994. Epub 2020 Mar 18.
No abstract available

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic / statistics & numerical data
  • Data Collection / methods
  • Data Collection / statistics & numerical data
  • Diabetes Mellitus, Type 1 / complications
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy
  • Diabetic Ketoacidosis / chemically induced
  • Diabetic Ketoacidosis / epidemiology*
  • Drug Approval / organization & administration*
  • Drug Approval / statistics & numerical data
  • Glycosides / administration & dosage
  • Glycosides / adverse effects*
  • Humans
  • Phlorhizin / administration & dosage
  • Phlorhizin / adverse effects
  • Sodium-Glucose Transporter 2 Inhibitors / administration & dosage
  • Sodium-Glucose Transporter 2 Inhibitors / adverse effects*
  • Treatment Outcome
  • United States / epidemiology
  • United States Food and Drug Administration

Substances

  • Glycosides
  • Sodium-Glucose Transporter 2 Inhibitors
  • (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
  • Phlorhizin

Grant support