Search results for "FDA update"
New labels warn against sharing multi-dose insulin pens
In an effort to reduce the risk of infection spread, the FDA recently required additional label warnings about sharing of multi-dose diabetes pen devices, which are intended for single patient use only.
https://diabetes.acponline.org/archives/2015/03/13/9.htm
13 Mar 2015
Aflibercept approved for diabetic retinopathy in diabetic macular edema
Aflibercept (Eylea) has received expanded approval to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME), the FDA recently announced.
https://diabetes.acponline.org/archives/2015/04/10/7.htm
10 Apr 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
New weight loss device approved
A new balloon device (the ReShape Dual Balloon) was recently approved by the FDA to treat obesity without invasive surgery.
https://diabetes.acponline.org/archives/2015/08/14/6.htm
14 Aug 2015
Warning on DPP-4 inhibitors and insulin recall
Dipeptidyl peptidase-4 (DPP-4) inhibitors may cause joint pain that can be severe and disabling, and some insulin pods may fail, the FDA recently warned.
https://diabetes.acponline.org/archives/2015/09/11/6.htm
11 Sep 2015
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
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
Insulin needles failing to deploy
Several lots of the OmniPod Insulin Management System were affected by a recent field safety notification about needle mechanisms failing to deploy or demonstrating a delay in deployment.
https://diabetes.acponline.org/archives/2015/12/11/7.htm
11 Dec 2015
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
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