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COMMENTS AND OPINIONS
No Black Box on Phosphosoda
Michael Caswell, PhD
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There were both factual errors and critical omissions in the articles by Khurana et al1 and Roy and Bianchi2 that are deserving of clarification. In their article, Khurana et al1(pp593-594) stated " . . . the Food and Drug Administration (FDA) issued a Black Box warning recommending that OSPS [oral phosphosoda solution] . . . " without reference. Their statement is incorrect. The FDA has never issued a black box warning for Fleet Phospho-soda (C.B. Fleet Company Inc, Lynchburg, Virginia) or any other OSPS product. As cited in Roy and Bianchi,2 the FDA issued a Science Background Paper and a MedWatch Alert in May 2006 on "Oral Sodium Phosphate (OSP) Products for Bowel Cleansing" (http://www.fda.gov/cder/drug/infopage/OSP_solution/default.htm), but no OSPS product is required to bear or bears a black box warning. For information on warnings and contraindications to use of the products and other safety-related information, see http://www.fleetlabs.com/healthcare_professionals_notices.php, as well as the Physician's Desk . . . [Full Text of this Article] AUTHOR INFORMATION
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