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.
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.
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
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
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 recently approved a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. ... This is the first glucose meter cleared by the FDA for use in these patients.
The benefits of the angiotensin-receptor blocker olmesartan continue to outweigh the risks for diabetic patients, according to the FDA. ... Overall, the FDA determined that the studies do not clearly show an increased cardiovascular risk and do not
Aflibercept (Eylea) has received expanded approval to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME), the FDA recently announced. ... Aflibercept was previously approved to treat wet age-related macular degeneration and DME