Search results for "FDA update"
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
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
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
Incretin mimetics' effects on pancreas under investigation
The FDA is investigating reports of possible increased risk of pancreatitis and precancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.
https://diabetes.acponline.org/archives/2013/05/10/13.htm
10 May 2013
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
More metformin recalled due to nitrosamine impurities
Another company recalled four lots of metformin hydrochloride extended-release tablets USP (500 and 750 mg) this month due to the detection of excess levels of N-nitrosodimethylamine, a probable carcinogen.
https://diabetes.acponline.org/archives/2020/11/13/10.htm
13 Nov 2020
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
Recall, warning, and a new generic drug
Insulin cartridge holders were recalled, patients were warned about pre-owned test strips, and a generic form of rosiglitazone maleate and metformin hydrochloride was approved.
https://diabetes.acponline.org/archives/2017/07/14/8.htm
14 Jul 2017