2014 ACG-FDA Public Forum - Toward Improving the Quality of Colonoscopy - Evidenced-Based State ofthe Art in Bowel Preparation

Sep 27, 2026

2014 ACG-FDA Public Forum materials focus on improving colonoscopy quality through evidence-based bowel preparation. The agenda covers FDA perspectives on registration trials, optimal dosing and formulation of bowel-prep regimens, safety issues for over-the-counter and prescription products, and clinical or trial endpoints for preparation assessment. Content reviews FDA-approved cleansing products and uses case studies to discuss safety signals, including phosphate nephropathy with sodium phosphate products and ischemic colitis with HalfLytely. It also outlines FDA actions such as boxed warnings, medication guides, communication plans, and postmarketing trials comparing OSP and PEG-based preparations.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages112

Reading Time4 h 42 min

AccessFree to download

Agenda & Speakers

FDA Perspective on Bowel Preparation Registration Trials

Evidence for Optimal Dosing and Formulation

Safety Issues for OTC and Prescription Products

Optimal Endpoints for Assessing Bowel Preparation

ACG 2014 Bowel Prep Workshop Outline

Case Studies: Safety

Visicol / Osmoprep (phosphate nephropathy)

HalfLytely (ischemic colitis)

General Efficacy Remarks

Shared Goals

Endpoint Selection

Noninferiority Design Considerations

Choice of Regimen (day before, same day, or split dose)

“Combination Rule”

FDA Approved Bowel Cleansing Products

Oral Sodium Phosphate Preps

Polyethylene Glycol Preps

Sulfate Salt Preps

Others (Combinations)

Case Study: Sodium Phosphate Preps

Literature and AERS Findings

FDA Labeling and Alerts (2006)

2008 AERS Analysis and Outcomes

Resulting Regulatory Actions

Case Study: HalfLytely

2014: ACG-FDA Public Forum American College of Gastroenterology & U.S. Food and Drug Administration Toward Improving the Quality of Colonoscopy: Evidenced-Based State ofthe Art in Bowel Preparation Sponsored by the ACG FDA Related Matters Committee Agenda & Speakers Moderators: Lawrence Cohen, MD, FACG Robert Fiorentino, MD (FDA) Topics: The FDA perspective on bowel preparation registration trials (Robert Fiorentino, MD) What is the evidence for an optimal dosing scheme and bowel preparation formulation? (Paul Moayyedi, MD) What are the immediate and delayed safety issues surrounding over the counter and prescription bowel preparations? (Philip Schoenfeld, MD) What are the optimal endpoints for assessing bowel preparation in clinical practice or trials?(Douglas Rex, MD) Open Forum Discussion ACG 2014 Bowel Prep Workshop FDA Perspective Robert P. Fiorentino, M.D. , M.P.H. FDA, Division of Gastroenterology & Inborn Errors October 2014 Outline • Case Studies: Safety – Visicol / Osmoprep (phosphate nephropathy) – HalfLytely (ischemic colitis) • General Efficacy Remarks – Shared Goals – Endpoint Selection – Noninferiority design considerations – Choice of Regimen –(day before, same day or split dose?) – “Combination Rule” FDA Approved Bowel Cleansing Products Oral Sodium Phosphate Preps – Visicol (2000) – OsmoPrep (2006) Polyethylene Glycol Preps – GoLYTELY (4L) (1984) – Colyte (4L) (1984) – OCL Solution(4L) (1986) – NuLYTELY(4L) (1991) – MoviPrep (2L) (2006) Sulfate Salt Preps – SUPREP (2010) Others (Combinations) – HalfLytely (2004, 2007, 2010) – Prepopik (2012) – Suclear (2013) Case Study: Sodium Phosphate Preps • In September 2003, Desmeules et al published a case report of acute phosphate nephropathy followed by persistent renal insufficiency in a 71-year old woman who took 90 mL of an OSP solution as a cathartic. • In November 2005, Markowitz et al published a case series study describing 21 biopsy-proven cases of acute phosphate nephropathy in patients who took OSP and had no history of hypercalcemia or superimposed renal pathology. – 18 patients were diagnosed with acute renal failure within 2 months of colonoscopy, and all were diagnosed within 5 months. • FDA review of the above literature and the FDA Adverse Event Reporting System (AERS) revealed 10 additional unique cases of renal failure associated with use of OSP solution and 10 cases of renal failure associated with use of OSP tablets. Case Study: Sodium Phosphate Preps • In 2006, FDA took steps to include information regarding the risk of acute phosphate nephropathy associated with the use of OSP products for bowel cleansing to the WARNINGS section of the existing prescription labeling for Visicol, as well as OsmoPrep. • In 2006, the Agency issued an FDA Alert on OSP products for bowel cleansing (2006 FDA Alert), which included information for healthcare professionals and patients, and a science background paper (links provided below). For more information: [http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126084.htm](http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126084.htm)[ ](http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126084.htm)[http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm161581.htm](http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm161581.htm) Case Study: Sodium Phosphate Preps • In 2008, FDA conducted a new analysis of the AERS reports involving OSP-associated acute phosphate nephropathy, as well as a review of the recent medical literature – Between 2006 to 2008 there were 20 reported cases of kidney injury associated with the use of OsmoPrep, 3 were biopsy-proven cases of acute phosphate nephropathy. – The ons

FAQs

What does the forum cover regarding bowel preparation for colonoscopy?

It addresses FDA perspectives on bowel preparation registration trials, evidence for optimal dosing and formulation, safety issues for OTC versus prescription products, and endpoints for assessing bowel preparation in practice or clinical trials.

What safety risks are highlighted for sodium phosphate (OSP) bowel cleansing products?

The materials describe acute phosphate nephropathy leading to serious kidney injury, with cases progressing to dialysis or kidney transplant and rare instances of death, supported by published case reports, case series, and FDA AERS review.

How did FDA actions change recommendations for OSP products?

FDA included risk information in warnings, issued FDA alerts, established boxed warnings, created a medication guide and communication plan, and required postmarketing clinical trials to evaluate safety.

Sep 27, 2026

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