Search results for "FDA update"
Extended-release metformin recalled due to impurity
After recommending that several manufacturers recall the diabetes drug due to excess levels of N-nitrosodimethylamine, the FDA is assessing whether the recalls will result in shortages.
https://diabetes.acponline.org/archives/2020/06/12/9.htm
12 Jun 2020
Device approved to treat diabetic foot ulcers
The shock-wave system is intended to be used with standard diabetic ulcer care in patients ages 22 years and older with ulcers lasting more than 30 days.
https://diabetes.acponline.org/archives/2018/01/12/6.htm
12 Jan 2018
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
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
Glucagon emergency kits recalled due to loss of potency
A product complaint reported that the vial of glucagon in the kit was in liquid form instead of powder form. This could cause it to fail to treat severe hypoglycemia due to loss of potency, the FDA said.
https://diabetes.acponline.org/archives/2021/10/08/8.htm
8 Oct 2021
Boxed warning on amputation risk removed from canagliflozin label
Recent studies have found a lower risk of leg and foot amputation than previous studies, which in 2017 had prompted the FDA to add the warning to the sodium-glucose cotransporter-2 inhibitor.
https://diabetes.acponline.org/archives/2020/09/11/9.htm
11 Sep 2020
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 testing finds negligible levels of nitrosamine impurity
Levels of N-nitrosodimethylamine found in metformin products ranged from not detectable to low, and there are no U.S. recalls at this time.
https://diabetes.acponline.org/archives/2020/02/14/8.htm
14 Feb 2020
Insulin pumps recalled due to incorrect dosing
The manufacturer of the pumps, which deliver insulin to patients with type 1 diabetes, has received a total of 26,421 complaints and is aware of 2,175 injuries and one death.
https://diabetes.acponline.org/archives/2020/03/13/8.htm
13 Mar 2020
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