Search results for "FDA update"
Continuous glucose monitoring system approved to direct therapy, but daily fingersticks still needed
The G5 Mobile Continuous Glucose Monitoring System is now approved for patients and clinicians to use results directly from the device to make diabetes treatment decisions.
https://diabetes.acponline.org/archives/2017/01/13/8.htm
13 Jan 2017
New indication approved for empagliflozin
Empagliflozin (Jardiance) is approved for a new indication—to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.
https://diabetes.acponline.org/archives/2016/12/09/6.htm
9 Dec 2016
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
New daily injection approved for adults with type 2 diabetes
Lixisenatide (Adlyxin), a once-daily injection, was approved by the FDA on July 28 to improve glycemic control in adults with type 2 diabetes.
https://diabetes.acponline.org/archives/2016/08/12/8.htm
12 Aug 2016
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
Safety alert and advice on CT scanning in patients with insulin pumps
The presence of an insulin pump should not preclude an appropriate and medically indicated CT scan, the FDA said.
https://diabetes.acponline.org/archives/2016/04/08/6.htm
8 Apr 2016
New warnings on medications containing saxagliptin, alogliptin
New warnings will be placed on saxagliptin and alogliptin about the potential risk of heart failure, particularly in patients with heart or kidney disease, the FDA announced on April 5.
https://diabetes.acponline.org/archives/2016/04/08/5.htm
8 Apr 2016
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
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
Rosiglitazone REMS ends, new insulin approved
The FDA has determined that the Risk Evaluation and Mitigation Strategy is no longer necessary to ensure that the benefits of rosiglitazone-containing drugs outweigh their risks.
https://diabetes.acponline.org/archives/2016/01/08/6.htm
8 Jan 2016