The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016. ... The FDA has issued draft guidance to help ensure the accuracy, reliability, and safety of blood glucose monitoring test systems for
Six batches of GlucaGen HypoKit (glucagon [rDNA origin] for injection) were recalled due to the possibility of needle detachment, the FDA recently announced. ... Manufacturer Novo Nordisk Inc. issued the recall in response to reports of needles detaching
The FDA has approved ertugliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, as an adjunct to diet and exercise for adult patients with type 2 diabetes, as of Dec. ... The most common adverse reaction is female genital mycotic infections. The
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. ... spine. The FDA continues to evaluate the risk of bone fractures with other
Sodium-glucose cotransporter-2 (SGLT2) inhibitors, including canagliflozin, dapagliflozin, and empagliflozin, may cause ketoacidosis, the FDA recently warned. ... The FDA recommend clinicians discontinue SGLT2 inhibitors if acidosis is confirmed and take
The FDA recently approved the first hemoglobin A1c (HbA1c) test specifically labeled for diagnosing diabetes. ... The FDA recently approved the first hemoglobin A1c (HbA1c) test specifically labeled for diagnosing diabetes (COBAS INTEGRA 800 Tina-quant
the FDA recently warned.
The clinical study did not meet its original end point, but the FDA concluded that the benefits outweighed risks of the device, according to a press release. ... Other adverse events included pain, heartburn, problems swallowing, belching, mild nausea,
The SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled because they may report falsely low blood glucose levels, the FDA announced