Health Canada Warns That Use of Oral Sodium Phosphate Products For Bowel Cleansing May Lead To Kidney Injury

Warning
2009-37
March 5, 2009
For immediate release

OTTAWA - Health Canada is warning Canadians not to use oral sodium phosphate products as bowel cleansers ("purgatives"), unless recommended in an individual case by a health care practitioner, as they may cause serious adverse effects. Oral sodium phosphate products are currently available over-the-counter as natural health products in Canada. These products have a long history of safe use as laxatives, but when taken for bowel cleansing (purgative dose) they have been associated with serious adverse effects, including electrolyte disturbances and kidney injury.

In Canada there are three authorized oral sodium phosphate products that have instructions for laxative and purgative use on their labels: Phoslax (by: Odan Laboratories Ltd.; NPN 80000689), Fleet Phospho-Soda Oral Laxative (by Johnson & Johnson Merck Consumer Pharmaceuticals; NPN 02206218) and Phosphate Solution (by Pharmascience Inc.; NPN 02230399) which is also sold under the following brand names: Option + Phosphates Solution, Pharmasave Phosphates Solution and Reserve Phosphates Solution. Health Canada is working with these companies and is taking appropriate actions to reduce risk and ensure health and safety to Canadians. Johnson & Johnson Merck Consumer Pharmaceuticals has notified Health Canada that they have voluntarily discontinued the sale of the Fleet Phospho-Soda product in Canada.

The instructions for purgative use on the labels of these products should no longer be followed, unless recommended by a health care practitioner. These products are still considered to be safe and effective for laxative use. Canadian consumers are also cautioned not to use unauthorized health products containing oral sodium phosphate with a purgative dose for bowel cleansing.

Health Canada received 53 Adverse Reaction Reports in association with oral sodium phosphate products, of which 30 case reports involved kidney dysfunction including 27 reported as serious. Other adverse reactions included gastrointestinal symptoms, cardiovascular and neurological problems, and allergic reactions. Canadians who have used an oral sodium phosphate product and are concerned about their health should consult with a health care practitioner.

Health Canada previously issued the following risk communications related to oral sodium phosphate products issued in December 2005 entitled: Important Safety Information on Fleet Phospho-Soda (Sodium Phosphates Oral Solution.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada Web site
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to:
    Canada Vigilance Program
    Health Canada
    AL 0701C
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this Web site.

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Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709