Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Warns of Link Between SGLT2 Inhibitors and Serious Genital Infection

By The U.S. Food and Drug Administration | August 30, 2018

FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin (see FDA-Approved SGLT2 Inhibitors). In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

(Source: The U.S. Food and Drug Administration) 

Related Articles Read More >

GSK
GSK finalizes Affinivax acquisition 
vaccine
U.S. government makes an additional 442,000 monkeypox vaccine doses available 
Biogen logo
Biogen is scaling back space outside Boston
Fresenius Kabi
Fresenius Kabi plans to add 2D barcodes to its pharmaceutical portfolio

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards