![]() ![]() However, Kayexalate was approved in 1958-four years before passage of Kefauver-Harris Drug Amendments. ![]() “When Kayexalate is written, what’s given is a premixed preparation of the SPS resin in sorbitol.”īecause it has FDA approval, one would assume there’s adequate evidence supporting its effectiveness. “Kayelate has become synonymous with SPS-it’s kind of like Kleenex or Xerox,” said Sterns. The Kayexalate name is still widely used, even though generic preparations are most commonly given. Because of its potential to cause severe constipation, SPS is usually given with sorbitol, a widely used over-the-counter osmotic laxative. Sodium polystyrene sulfonate is an ion exchange resin designed to exchange sodium for potassium in the colon. ![]() We urge health care professionals and patients to report side effects involving Kayexalate or other sodium polystyrene sulfonate products to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.Grandfathered drug predates modern drug approval process If the studies conducted by the Kayexalate manufacturer, Concordia Pharmaceuticals, confirm significant interactions with other medications, FDA will require all manufacturers of sodium polystyrene sulfonate products to update the drug labels to include information about these drug interactions. Health care professionals should monitor blood levels or clinical response to the other medications when appropriate. This includes both prescription medications, such as antibiotics, blood pressure lowering agents and blood thinners, and those purchased over-the-counter without a prescription, such as antacids and laxatives. To reduce this potential risk, prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours. Similar to Veltassa, Kayexalate may also bind to other medications administered by mouth. The label for Veltassa contains a warning not to take other orally administered medications within 6 hours of taking Veltassa. Such binding could decrease the effects of these medications. 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. 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. Patients should not stop taking their potassium-lowering drugs without talking to their health care professional. When people have too much potassium in their blood it can cause problems with heart rhythm, which in rare cases can be fatal. Potassium is a mineral that helps the body function properly. They work by binding potassium in the large intestine so it can be removed from the body. Kayexalate (sodium polystyrene sulfonate) and generic brands Kionex and SPS are used to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. Food and Drug Administration (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. ![]()
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