OTC Oral Sodium Phosphates Remove Bowel Cleansing Indication in Canada

Health Canada announced Wednesday that over-the-counter oral sodium phosphate products in Canada are no longer indicated for bowel cleansing before a colonoscopy or other medical procedures, as such use has been linked to potentially life-threatening kidney damage.

There are currently only two oral sodium phosphate products available in Canada that are sold over the counter, Phoslax by Odan Laboratories, Ltd. and Phosphates Solution by Pharmascience, Inc. These products will no longer indicate bowel cleansing as a potential use on their label.

A third product, Fleet Phospho-Soda Oral Laxative, was removed from the market in both Canada and the United States after the FDA warned in December 2008 that oral sodium phosphate solutions used during colonoscopy prep increase the risk of a kidney injury, known as acute phosphate nephropathy.

Over-the-counter oral sodium phosphate products, which were not approved for use as a bowel cleanser in the United States, have been widely used as an alternative to prescription products during colonoscopy prep.

Fleet Phospho-Soda, which was manufactured and sold by C.B. Fleet Company in the United States, was actively marketed for the unapproved use of the laxative at double doses to clear out the bowels, and C.B. Fleet currently faces a number of oral sodium phosphate lawsuits for failing to adequately warn about the risk of kidney injury.

More than 150 Fleet Phospho-soda lawsuits have been filed against C.B. Fleet in the United States. While most of the cases were filed after the recall, some date back to 2004. All federal oral sodium phosphate litigation involving Fleet Phospho-soda has been consolidated in an MDL, or multidistrict litigation, which is centralized in the Northern District of Ohio for pretrial proceedings.

Acute phosphate nephropathy from oral sodium phosphate products like Fleet Phospho-Soda can result in renal failure, the need for dialysis treatment, a kidney transplant or death. It is caused by the formation of calcium phosphate crystals within the renal tubes.

The warning issued by FDA in December 2008 about the risk of acute kidney injury from oral sodium phosphate products indicated that over-the-counter products should not be used at high doses as a bowel cleanser. That same day, C.B. Fleet issued a Fleet Phospho soda recall and removed the laxative from the market.

In March 2009, Health Canada issued a statement warning Canadians about oral sodium phosphate products for bowel prep, indicating they should not be used unless they are specifically recommended by a doctor. On August 5, 2009, they updated the public warning to confirm that the products have been relabeled to remove bowel cleansing, or “purgative”, indications. They now state that oral sodium phosphate products should only be used as a laxative.