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.

Authors

Michael Fralick^{1

2}, Aaron S Kesselheim²

Affiliations

¹ Sinai Health System and the Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
² Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

PMID: 32189390
DOI: 10.1002/pds.4994

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

CIHR/Canada