FDA Alerts
FDA Approves New Use of Glucose Monitoring System for Hospitals
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized.
FDA Allows Marketing of Kidney Injury Test
Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test.
Baxter Recalls Dialysis Solution
Baxter International Inc. announced today it is voluntarily initiating a recall in the United States of two lots of DIANEAL Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level.
Procysbi Approved for Rare Genetic Condition
The US Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults.
Tolvaptan has Liver Injury Risk Says FDA
Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca.
Afinitor for Non-Cancerous Kidney Tumors
The U.S. Food and Drug Administration approved Afinitor ( everolimus ), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas ) not requiring immediate surgery in patients with tuberous sclerosis complex ( TSC ).
FDA: Blood Pressure Medication Warning
The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors ( ACEIs ) and angiotensin receptor blockers ( ARBs ) in patients with diabetes or kidney (renal) impairment.
FDA Drug Safety Communication: Tekturna
The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors ( ACEIs ) and angiotensin receptor blockers ( ARBs ) in patients with diabetes or kidney (renal) impairment.
FDA Approves Soliris For Rare Pediatric Blood Disorder
The U.S. Food and Drug Administration today approved Soliris ( eculizumab ) to treat patients with atypical hemolytic uremic syndrome ( aHUS ), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.
FDA Drug Safety Communication: Reclast
The U.S. Food and Drug Administration (FDA) has approved an update to the drug label for Reclast ( zoledronic acid) to better inform healthcare professionals and patients of the risk of kidney (renal) failure.