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FDA Medwatch Alert: Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing

Posted 6 Sep 2017 by

ISSUE: FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines. To reduce this likelihood, we recommend separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours. We are updating the sodium polystyrene sulfonate drug labels to include information about this dosing separation. BACKGROUND: Sodium polystyrene sulfonate is used to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. It works by binding with potassium in the intestines so it can be removed from the body. Potassium is a mineral that helps ... Read more

Related support groups: Hyperkalemia, Sodium Polystyrene Sulfonate, Kayexalate, Kionex, Kalexate

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, Sodium Polystyrene Sulfonate, Kayexalate

FDA Medwatch Alert: Sodium Polystyrene Sulfonate Suspension

Posted 16 Jul 2008 by

[Posted 07/16/2008] Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product. Read more

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