The agency offered new recommendations after receiving reports of patients using standard pen needles to inject insulin without removing the inner needle cover.
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. 25.
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 approval is an expanded indication for the device, which covers the ulcer and allows skin and tissue to regenerate and heal the wound.
The FDA recently approved the first hemoglobin A1c (HbA1c) test specifically labeled for diagnosing diabetes.
Several lots of the OmniPod Insulin Management System were affected by a recent field safety notification about needle mechanisms failing to deploy or demonstrating a delay in deployment.
First continuous glucose monitoring system approved to be used with other devices | ACP Diabetes Monthly
The system is the first approved to be used with other diabetes devices, such as automated insulin-dosing systems, insulin pumps, or blood glucose meters, according to the FDA.
Aliskiren-containing medications are contraindicated with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with diabetes.
A once-daily combination pill of dapagliflozin and metformin HCl extended-release (Xigduo XR) was recently approved by the FDA.