Six batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection) were recalled due to the possibility of needle detachment, the FDA recently announced.
The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.
The injection is approved to improve glucose control in patients ages three years and older with type 1 diabetes and in adult patients with type 2 diabetes.
As an adjunct to diet and exercise, the drug was approved as monotherapy and for use in fixed-dose combinations with metformin or sitagliptin.
The software analyzes images of the eye taken with a retinal camera and offers one of two results: “more than mild diabetic retinopathy detected: refer to an eye care professional” or “negative for more than mild diabetic retinopathy; rescreen
The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip may report falsely low blood glucose levels.
Twenty lots of Abbott's FreeStyle and FreeStyle Lite blood glucose test strips were recalled.
The FDA on Sept. 10 released a strengthened warning on canagliflozin (Invokana, Invokamet) about increased risk of bone fractures and decreased bone mineral density.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned.
The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016.