Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned.
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.
The approval is an expanded indication for the device, which covers the ulcer and allows skin and tissue to regenerate and heal the wound.
Two lots of metformin hydrochloride oral solution (Riomet), 500 mg/5 mL, were recalled due to fungal contamination, the FDA said.
The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.
Empagliflozin (Jardiance) is approved for a new indication—to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.
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.
A once-daily combination pill of dapagliflozin and metformin HCl extended-release (Xigduo XR) was recently approved by the FDA.
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.