Search results for "FDA update"
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
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 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
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
Semaglutide injection approved for chronic weight management
First approved to treat type 2 diabetes in 2017, the drug has a new indication for chronic weight management in adults with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related condition, such as type 2 diabetes, and those with a BMI of 30 kg/m2 or greater.
https://diabetes.acponline.org/archives/2021/06/11/11.htm
11 Jun 2021
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
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
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