Petition Urges FDA To Take Oral Sodium Phosphate Laxatives Off OTC Market
This article was originally published in The Tan Sheet
Executive Summary
FDA should switch oral sodium phosphate bowel cleansers from over-the-counter to prescription status due to safety concerns or take them off the market altogether, according to a Sept. 20 citizen petition
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The Laszlo & Associates law firm says C.B. Fleet Company has removed the "bowel cleanser" indication from the packaging for its nonprescription laxative after dozens of lawsuits were filed by people who suffered "acute renal failure and chronic kidney disease" after using the product as a bowel cleanser prior to colonoscopies and surgical procedures. In an Aug. 9 release, New York-based Laszlo says it is among the law firms representing clients from more than 20 states in suits against Lynchburg, Va.-based Fleet stemming from use of Phospho-Soda as a bowel cleanser. Following an FDA safety alert in May 2006, the firm recommended "follow the special instructions from your doctor exactly" when using its oral sodium phosphate products for bowel cleansing. FDA's announcement cited an association between bowel cleansers and acute phosphate nephropathy, a type of acute renal failure (1"The Tan Sheet" May 15, 2006, p. 10)...
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A recommendation by C.B. Fleet that consumers "follow the special instructions from your doctor exactly" when using oral sodium phosphate products for bowel cleansing was issued May 9 following an FDA safety alert