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FDA Issues Warning on Bowel-Clearing Drugs; C.B. Fleet Announces Voluntary Recall

December 16, 2008 – Late last week, the FDA announced that they will be adding very strong safety warnings to bowel-clearing drugs that are used by patients in preparation for a scheduled colonoscopy. This is in light of some reports of kidney damage in several patients. According to Federal health officials, some of this could be attributed to patients not adequately following instructions correctly, such as drinking plenty of water with the medication.

In response to this warning, C.B. Fleet Company issued a voluntary recall of their over-the-counter Fleet® Phospho-soda® products.

Dr. Mark Delegge, MD, Director of the MUSC Digestive Disease Center, noted that "sodium phosphate-containing colonoscopy preparation formulations have been around for a long time. These products are generally of small volume and therefore are sometimes better tolerated than the large-volume colonoscopy preparation solutions such as Polyethylene Glycol.

"However, it has been noted that these small-volume sodium phosphate preparations can be dangerous in patients with pre-existing kidney disease, resulting in worsening of the kidney disease, especially if enough liquid is not consumed with the sodium phosphate preparation. This has led to C.B. Fleet to recall their phosphasoda, an over-the-counter small-volume sodium phosphate preparation previously used frequently for colon preparation for colonoscopy. The large-volume preparations, such as Polyethylene Glycol, are still available."