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Hyperkalemia News

FDA Approves Supplemental New Drug Application for Veltassa Removing Boxed Warning Regarding Drug-Drug Interactions

Posted 30 Nov 2016 by

REDWOOD CITY, Calif., November 27, 2016 – Relypsa, Inc., a Vifor Pharma company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) with important updates to the label of Veltassa (patiromer) for oral suspension. Veltassa’s label no longer includes a Boxed Warning regarding the separation of Veltassa and other oral medications. The updated label recommends patients take Veltassa at least 3 hours before or 3 hours after other oral medications. This information is now detailed in the dosage and administration section (Section 2) and the drug interactions section (Section 7) of the label. In addition, data from the Veltassa drug-drug interaction program has been added to the Clinical Pharmacology section of the label (Section 12). “We are extremely pleased the FDA has approved these changes to Veltassa’s label, includi ... Read more

Related support groups: Hyperkalemia, Veltassa, Patiromer

FDA Approves Veltassa (patiromer) for Hyperkalemia

Posted 28 Oct 2015 by

October 21, 2015 – The U.S. Food and Drug Administration today approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. “Too much potassium in the blood can lead to dangerous, even fatal, changes in heart rhythm,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have treatment options for hyperkalemia available to patients.” Potassium, a mineral that is delivered to the body by food, is needed for cells to function properly. The kidneys remove potassium from the blood to maintain a proper balance of potassium in the body. But when the kidneys are not able to remove enough potassium from the blood, the level of potassium can get too high. Hyperkalemia typically occurs in ... Read more

Related support groups: Hyperkalemia, Veltassa, Patiromer

FDA Medwatch Alert: Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies

Posted 22 Oct 2015 by

ISSUE: FDA is requiring the Kayexalate manufacturer to conduct studies to investigate Kayexalate’s potential to bind to other medications administered by mouth – drug interactions that could affect how well the other medications work. The approved labeling for Kayexalate describes its potential to decrease absorption of lithium and thyroxine; however, extensive drug-drug interaction studies with Kayexalate have not been performed. During FDA’s review of another potassium-lowering drug, Veltassa (patiromer), we found that Veltassa bound to about half of the medications tested, some of which are commonly used in patients who require potassium-lowering drugs. Such binding could decrease the effects of these medications. The label for Veltassa contains a warning not to take other orally administered medications within 6 hours of taking Veltassa. Similar to Veltassa, Kayexalate may also bind ... Read more

Related support groups: Hyperkalemia, Kayexalate, Sodium Polystyrene Sulfonate

New Drug May Help Diabetic Kidney Disease Patients

Posted 14 Jul 2015 by

TUESDAY, July 14, 2015 – A new drug decreases dangerously high levels of potassium in people with diabetes-related kidney disease, a new study finds. Potassium is necessary for the heart, kidneys and other organs to work normally, but damage to the kidneys can cause potassium levels to increase to dangerous levels. This condition is called hyperkalemia. Elevated potassium levels are associated with sudden death – your heart stops, said lead researcher Dr. George Bakris, a professor of medicine at the University of Chicago. "High potassium is a problem seen in people with advanced kidney disease and advanced diabetes with kidney disease and with people with heart failure," Bakris explained. The new drug, patiromer, significantly reduced potassium levels when taken for a month, researchers found. Moreover, that effect lasted for a year. Patiromer is a powder you mix with water and drink ... Read more

Related support groups: Diabetes, Type 2, Hyperkalemia

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Novolin R, sodium bicarbonate, Humulin R, Kayexalate, sodium polystyrene sulfonate, insulin regular, Kionex, Novolin R PenFill, calcium chloride, view more... Kalexate, calcium gluconate, Novolin R Innolet, Veltassa, ReliOn / Novolin R, Kalcinate, Cal-G, Cal-GLU, Iletin II Regular Pork, patiromer, Neut, Velosulin BR, Iletin Regular, Bell / ans