Important safety information on pms-Sodium Phosphates Oral Solution with kidney impairment and nephrocalcinosis- For Health Professionals- Pharmascience Inc

Date: 2005-12-07

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Contact
MHPD

Health Canada Endorsed Important Safety Information on
Phosphates solution (oral sodium phosphates)

December 2, 2005

Subject: Safety Information on Phosphates solution (oral sodium phosphates) and kidney impairment.

Dear Health Care Professional:

Pharmascience Inc., following discussion with Health Canada, would like to inform you of important new safety information regarding pms-Sodium Phosphates Oral Solution (Fleet™).

PHOSPHATES SOLUTION has an action as a laxative or purgative, and is commonly used for relief of occasional constipation or for preparing the colon for x-ray or other endoscopic examination, or surgery. Caution must be exercised as electrolyte shifts may occur in patients with or without risk factors for electrolyte shifts if a dose of 45mL (contains 5760 mg of phosphorus) in a 24-hour period is exceeded. Three papers, involving seven case reports, have been published reporting nephrocalcinosis associated with renal failure following administration of Fleet^™ Phospho-Soda^®, or other oral sodium phosphate preparations, when used as a bowel cleanser. ^1-3 In some cases acute renal failure was followed by chronic renal impairment. Six of seven patients were hypertensive with five on an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and two also on diuretics. One patient had a relative contraindication (Hyperparathyroidism) to use of the product and another patient was given an overdose.

Pharmascience Inc, has until this date not received any spontaneous reports of renal failure associated with the use of Sodium Phosphates Oral Solution.

The prescribing Information has recently been modified to include that care should be taken to prescribe PHOSPHATES SOLUTION as a bowel cleanser by volumes, not “by the bottle,” per recommendations with a particular attention to known contraindications and adequate hydration. Patients should be encouraged to drink large amounts of clear liquids to prevent dehydration. Drinking large amounts of clear liquids also helps ensure that the patient’s bowel will be clean for the procedure.

A caution statement has been added to the prescribing information to state that nephrocalcinosis associated with transient renal insufficiency and renal failure has been very rarely reported in patients using sodium phosphates for bowel cleansing. Reporting rates determined on the basis of spontaneously reported post-market adverse events are generally presumed to underestimate the risks associated with drug treatments.

The identification, characterization, and management of marketed health product-related adverse events are directly dependent on the participation of health care professionals in adverse drug reaction reporting. Any occurrence of neprocalcinosis, renal failure or other serious and/or unexpected adverse events in patients receiving Phosphates solution (oral sodium phosphate) should be reported to Pharmascience Inc or Health Canada at the following addresses:

Your professional commitment in this regard has an important role in the well-being of your patients by contributing to early signal detection and informed drug use. Should you have any further questions or require additional information, please contact the Pharmascience Inc. Medical and Scientific Information Department at 1-888-550-6060 from 8:30am to 5pm, Eastern Standard Time, Monday to Friday. A copy of the letter will be posted on the  www.pharmascience.com and Health Canada websites.

Best Regards,

original signed by

Gaetano Gallo
Associate Director, Scientific Affairs
Pharmascience Inc.

References:

¹ Desmules S, Bergeron MJ, Isenring P. Acute phosphate nephropathy and renal failure. N Engl J Med 349; 1006-1007, 2003.

² Markowitz GS, Nasr SH, Klein P, et al. Renal failure due to acute nephrocalcinosis following oral sodium phosphate bowel cleansing. Hum Path 35 (6); 675-684, 2004.

³ Markowitz GS, Whelan, J, D’Agati VD. Renal failure following bowel cleansing with sodium phosphate purgative. Nephrol Dial Transplant 20; 850-851, 2005.