Search results for "FDA update"
Warning about serious genital infections in patients taking SGLT2 inhibitors
The FDA has identified 12 cases of necrotizing fasciitis of the perineum or Fournier's gangrene. All 12 patients were hospitalized and required surgery, and one died.
https://diabetes.acponline.org/archives/2018/09/14/8.htm
14 Sep 2018
FDA clears marketing of first interoperable insulin pump
The pump can be used with various components of diabetes therapy systems, including automated insulin dosing systems, continuous glucose monitors, and blood glucose meters.
https://diabetes.acponline.org/archives/2019/03/08/7.htm
8 Mar 2019
Extended-release metformin recalled due to nitrosamine impurities
A company recently expanded a recall of metformin hydrochloride extended-release tablets USP due to excess amounts of N-nitrosodimethylamine.
https://diabetes.acponline.org/archives/2021/01/08/7.htm
8 Jan 2021
Test strips recalled
The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip may report falsely low blood glucose levels.
https://diabetes.acponline.org/archives/2016/03/11/8.htm
11 Mar 2016
Glucose meter recalled due to incorrect unit of measure
The TRUE METRIX AIR Blood Glucose Meter displayed glucose results in mmol/L rather than mg/dL.
https://diabetes.acponline.org/archives/2020/05/08/7.htm
8 May 2020
SGLT2 inhibitors associated with ketoacidosis
Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned.
https://diabetes.acponline.org/archives/2015/06/12/8.htm
12 Jun 2015
FDA urges patients to use caution when injecting insulin with pen needles
The agency offered new recommendations after receiving reports of patients using standard pen needles to inject insulin without removing the inner needle cover.
https://diabetes.acponline.org/archives/2018/10/12/7.htm
12 Oct 2018
Cybersecurity warning issued for certain insulin pumps
The risks are related to the pumps' wireless communication with other devices, such as blood glucose meters and continuous glucose monitoring systems.
https://diabetes.acponline.org/archives/2019/07/12/6.htm
12 Jul 2019
Metformin solution recalled due to contamination
Two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL, were recalled due to fungal contamination, the FDA said.
https://diabetes.acponline.org/archives/2017/12/08/7.htm
8 Dec 2017
Liraglutide gets new cardiovascular indication
The FDA approved a new indication for liraglutide to reduce the risk of myocardial infarction, stroke, and cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
https://diabetes.acponline.org/archives/2017/09/08/8.htm
8 Sep 2017