Label Changes for:

Kayexalate (sodium polystyrene sulfonate) powder

September 2009

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

January 2011

WARNINGS

Colonic Necrosis
  • Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Kayexalate use.
  • Do not use in patients who do not have normal bowel function. This includes postoperative patients who have not had a bowel movement post surgery.
  • Do not use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction)
  • Discontinue use in patients who develop constipation. Do not administer repeated doses in patients who have not passed a bowel movement.

PRECAUTIONS

Sorbitol
  • Concomitant use of Sorbitol with Kayexalate has been implicated in cases of colonic intestinal necrosis, which may be fatal.
Pediatric Use
  • the word “Colonic” was replaced with “Intestinal.”

ADVERSE REACTIONS

  • “hypomagnesemia” was added after the words “hypokalemia, hypocalcemia.”
  • “colonic” was replaced with the word “intestinal” [seventh sentence of the first paragraph]
  • “Ischemic colitis” was added in front of the words, “gastrointestinal tract.” [the third bullet]
  • text deleted: "Magnesium-containing laxatives or sorbitol should not be used (See PRECAUTIONS, Drug Interaction)"

 

September 2009 

 

WARNINGS

Colonic Necrosis 
  • Cases of colonic necrosis and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Kayexalate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended.

 

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