A Systematic Review of Renal Impairment and Use of Oral Sodium Phosphate as a Bowel Cleanser
A Systematic Review of Renal Impairment and Use of Oral Sodium Phosphate as a Bowel Cleanser
Published: October 2009
Abstract
This is a systematic review to evaluate the risk of renal impairment with use of oral sodium phosphate (OSP) as a bowel cleanser. Publications citing OSP and renal failure or metabolic disorder were searched for in PubMed, Embase and CBFleet® company sources. In 32 randomiwed trials (n= 6,580), no clinically relevant renal adverse effects were reported. The only incontrovertible finding of an increased risk of acute renal injury from use of OSP as a bowel cleanser in North American epidemiological studies was observed in patients with pre-existing renal impairment. Renal events from published case reports arose mostly from North America, with 8.8% from Europe. Serious renal impairment reported from OSP use in Europe is very rare (1<10,000). The rarity of case reports of renal impairment due to OSP reported from Europe compared with North America may be due to differences in practice arising from its differing regulatory status.
Keywords
Renal impairment, adverse event, oral sodium phosphate, laxative, systematic review
Disclosure: Nawab Qizilbash is an employee of OXON Epidemiology Limited, a consulting company that provides Casen-Fleet with epidemiological, meta-analysis and pharmacovigilance services and data-mining of regulatory spontaneous adverse event databases. Angel Navarro is an employee of Casen-Fleet SA.
Received: 18 June 2009 Accepted: 3 July 2009
Correspondence: Nawab Qizilbash, OXON Epidemiology Ltd, 200 Northcote Road, London E17 7DH, UK. E: n.qizilbash@oxonepi.com
Removal of lesions identified by colonoscopy has been shown to substantially reduce the risk of future colorectal cancer and advanced adenomas.1 For this to happen, bowel cleansing to allow good visualisation of the colon is critical. Sub-optimal bowel preparation accounts for up to one-quarter of all colonoscopies.2 This results in lower caecal intubation rates, longer procedures, decreased polyp detection and more frequent repeat colonoscopies.2 The ideal preparation for a colonoscopy should be well tolerated, comfortable and safe for the patient, but also effective.
Oral sodium phosphate salts (OSPs) for bowel preparation have been used worldwide for many years for bowel cleansing prior to colonoscopy, radiological procedures and surgery. Many published randomised controlled trials and meta-analyses have demonstrated the safety and efficacy of OSP products for bowel cleansing.3–13 OSP products are established as first-line agents in terms of efficacy and tolerability.14
OSPs are osmotic laxatives that are hypertonic relative to serum. They act by drawing water into the lumen of the gut, following an osmotic gradient. Adequate hydration during bowel preparation is critical to attenuate the fluid loss that occurs with OSP use.2 Non-clinically important temporary changes in serum electrolytes include increases of serum phosphate and sodium and reductions of serum calcium and potassium.5,15–18 This kind of medication needs to be used according to the guidance included in the special precautions and contraindications sections of their summary of product characteristics (SPC).18 OSPs are no exception. When OSPs are administered according to the SPC, in the correct dose, in the correct patient and with the correct intake and hydration measures, the electrolyte changes attributable to sodium phosphate are generally transient and clinically inconsequential.10 Reported adverse events with OSPs, as stated in the SPC, include electrolyte disturbances, volume depletion and metabolic acidosis,6,15,19–23,18 although many of these events have been reported in patients who were prescribed a dose of OSP solution exceeding 90ml in a 24-hour period, in patients who did not receive proper hydration during bowel preparation or in patients with a medical contraindication to the product or in whom it should be used with caution.6
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Specialities:
- Gastroenterology
- Abdominal Gastroenterology
- Anorectal Disorders
- Bezoars & Foreign Bodies
- Diverticular Disease
- Esophageal Disorders
- Gastric & Peptic Disorders
- Gastroenteritis
- GI Bleeding
- GI Diagnostics
- Hepatic Disorders
- Inflammatory Bowel Disease
- Irritable Bowel Syndrome
- Lower GI Complaints
- Malabsorption Syndrome
- Nutrition
- Pancreatitis
- Tumors of the GI Tract
- Upper GI Complaints
- 27 August 2010






