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.
Empagliflozin (Jardiance) is approved for a new indication—to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease, the FDA announced on Dec. ... The most common side effects are urinary tract infections and
Insulin degludec injection (Tresiba) and insulin degludec/insulin aspart injection (Ryzodeg 70/30) were approved by the FDA on Sept. ... Both drugs are contraindicated for patients with diabetic ketoacidosis, according to an FDA.
The FDA has authorized marketing of the first interoperable insulin pump for patients with diabetes, the agency announced on Feb. ... The FDA reviewed data on dosing accuracy and reliability and assessed the pump's ability to safely communicate with
The FDA in January approved an expanded indication for the Integra Omnigraft Dermal Regeneration Matrix to treat certain diabetic foot ulcers that last longer than 6 weeks.
1 FDA press release announced. Insulet Corporation issued the notification because the failures or delays have resulted in 66 medical device reports, including 3 that required medical intervention. ... The FDA recommends that consumers using products
The FDA has approved the first treatment for severe hypoglycemia that can be administered without an injection, the agency announced on July 24.
A once-daily combination pill of dapagliflozin and metformin HCl extended-release (Xigduo XR) was recently approved by the FDA. ... It is the first once-daily combination of a sodium-glucose cotransporter 2 inhibitor and metformin to be approved by the
The FDA has permitted marketing of the Dermapace System, the first shock-wave device intended to treat diabetic foot ulcers, the agency announced on Dec.
A continuous glucose monitoring (CGM) system was approved and some infusion sets were recalled, the FDA recently announced. ... Approval was based on a study comparing readings from the device to those obtained by an established laboratory method,