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  Vol. 168 No. 20, November 10, 2008 TABLE OF CONTENTS
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COMMENTS AND OPINIONS
No Black Box on Phosphosoda

Michael Caswell, PhD

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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]


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