Search results for "FDA update"
CGM system approved for use without finger sticks
A continuous glucose monitoring (CGM) system was approved and some infusion sets were recalled, the FDA recently announced.
https://diabetes.acponline.org/archives/2017/10/13/6.htm
13 Oct 2017
Alert on canagliflozin and amputations
An ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with canagliflozin (Invokana, Invokamet), according to an FDA safety alert.
https://diabetes.acponline.org/archives/2016/06/10/5.htm
10 Jun 2016
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
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
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
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
FDA approves new treatment for diabetic foot ulcers
The approval is an expanded indication for the device, which covers the ulcer and allows skin and tissue to regenerate and heal the wound.
https://diabetes.acponline.org/archives/2016/02/12/6.htm
12 Feb 2016
First continuous glucose monitoring system with fully implantable glucose sensor approved
The sensor is coated with a fluorescent chemical that produces a small amount of light when exposed to blood glucose. Every five minutes, it sends glucose measurements to a compatible device that is running a device-specific mobile app.
https://diabetes.acponline.org/archives/2018/07/13/10.htm
13 Jul 2018
New long-acting insulin drugs approved
Insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) were approved by the FDA on Sept. 25.
https://diabetes.acponline.org/archives/2015/10/09/8.htm
9 Oct 2015
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