Search results for "FDA update"

Results 1 - 10 of about 100 for "FDA update".

FDA issues draft guidance on blood glucose monitors | ACP Diabetes Monthly

The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016.

Glucagon recalled due to detaching needles | ACP Diabetes Monthly

Six batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection) were recalled due to the possibility of needle detachment, the FDA recently announced.

Test strips recalled | ACP Diabetes Monthly

The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip may report falsely low blood glucose levels.

Follow-on insulin lispro approved | ACP Diabetes Monthly

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.

Ertugliflozin approved as adjunct treatment for type 2 diabetes | ACP Diabetes Monthly

As an adjunct to diet and exercise, the drug was approved as monotherapy and for use in fixed-dose combinations with metformin or sitagliptin.

Warning on risks of canagliflozin | ACP Diabetes Monthly

The FDA on Sept. 10 released a strengthened warning on canagliflozin (Invokana, Invokamet) about increased risk of bone fractures and decreased bone mineral density.

SGLT2 inhibitors associated with ketoacidosis | ACP Diabetes Monthly

Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned.

New warnings for fluoroquinolones about risk of hypoglycemic coma | ACP Diabetes Monthly

The labeling changes for fluoroquinolones will also make the mental health side effects more prominent and more consistent across the drug class.

First AI device approved to detect diabetes-related eye problems | ACP Diabetes Monthly

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

Test strips recalled | ACP Diabetes Monthly

Twenty lots of Abbott's FreeStyle and FreeStyle Lite blood glucose test strips were recalled.

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