FDA Alerts
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.
FDA: Modified dosing recommendations for Erythropoiesis-Stimulating Agents
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals of modified recommendations for more conservative dosing of erythropoiesis-stimulating agents ( ESAs ) in patients with chronic kidney disease (CKD) to improve the safe use of these drugs.
FDA Alert For Nulojix
Bristol-Myers Squibb (BMS) informed healthcare professionals about the risk evaluation and mitigation strategy ( REMS ) that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of post-transplant lymphoproliferative disorder ( PTLD ) and progressive m ultifocal l eukoencephalopathy ( PML ), both of which can be fatal.
FDA Approves Nulojix For Kidney Transplant Patients
The U.S. Food and Drug Administration today approved Nulojix ( belatacept ) to prevent acute rejection in adult patients who have had a kidney transplant.
Preventing Rejection
The U.S. Food and Drug Administration (FDA) today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients.