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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

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