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 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
FDA issues draft guidance on blood glucose monitors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 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
Do not use unauthorized devices for diabetes management, FDA warns
Use of such devices, either alone or with authorized devices, could result in inaccurate glucose level readings or unsafe insulin dosing, potentially leading to death or injury.
https://diabetes.acponline.org/archives/2019/06/14/7.htm
14 Jun 2019
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
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
First noninjection GLP-1 receptor agonist approved
The FDA has approved an oral formulation of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, to help improve blood glucose control in adults with type 2 diabetes.
https://diabetes.acponline.org/archives/2019/10/11/9.htm
11 Oct 2019
Metformin may contain nitrosamine impurity
The FDA is investigating whether metformin in the U.S. market contains N-nitrosodimethylamine. Low levels of the impurity have been found in the drug in other countries; however, there are no U.S. recalls at this time.
https://diabetes.acponline.org/archives/2019/12/13/9.htm
13 Dec 2019
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