Search results for "FDA update"
New warnings for fluoroquinolones about risk of hypoglycemic coma
The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.
https://diabetes.acponline.org/archives/2018/08/10/9.htm
10 Aug 2018
FDA issues draft guidance on blood glucose monitors
The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016.
https://diabetes.acponline.org/archives/2018/12/14/6.htm
14 Dec 2018
FDA clears marketing of mobile app for automated insulin dosing in type 1 diabetes
The prescription-only mobile application is intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older.
https://diabetes.acponline.org/archives/2023/02/10/6.htm
10 Feb 2023
FDA authorizes marketing of first interoperable, automated insulin dosing controller
The device automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.
https://diabetes.acponline.org/archives/2020/01/10/6.htm
10 Jan 2020
Warning on risks of canagliflozin
The FDA on Sept. 10 released a strengthened warning on canagliflozin (Invokana, Invokamet) about increased risk of bone fractures and decreased bone mineral density.
https://diabetes.acponline.org/archives/2015/10/09/7.htm
9 Oct 2015
Nearly 1.5 million insulin syringes recalled
Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
https://diabetes.acponline.org/archives/2021/07/09/8.htm
9 Jul 2021
Metformin recalled due to nitrosamine impurity
The recall includes two lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
https://diabetes.acponline.org/archives/2021/07/09/9.htm
9 Jul 2021
FDA approves new heart failure indication for SGLT-2 inhibitor
Originally approved in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes, the sodium-glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
https://diabetes.acponline.org/archives/2022/03/11/10.htm
11 Mar 2022
First noninjection treatment for severe hypoglycemia approved
The nasal powder is indicated for the emergency treatment of severe hypoglycemia in patients with diabetes ages 4 years and older.
https://diabetes.acponline.org/archives/2019/08/09/8.htm
9 Aug 2019
Glucagon recalled due to detaching needles
Six batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection) were recalled due to the possibility of needle detachment, the FDA recently announced.
https://diabetes.acponline.org/archives/2016/09/16/8.htm
16 Sep 2016