Health Canada Removes Purgative Use from Label for Over-the-Counter Oral Sodium Phosphate Products

Information Update
2009-125
August 5, 2009
For immediate release

OTTAWA - Further to the Public Warning issued March 5, 2009, Health Canada is informing Canadians that over-the-counter oral sodium products are no longer indicated for bowel cleansing. These products have either been voluntarily relabelled to remove the bowel cleansing (i.e., “purgative”) indication, or discontinued from the Canadian market. Oral sodium phosphate products should only be used as a laxative.

In March, Health Canada warned Canadians not to use over-the-counter oral sodium phosphate products as bowel cleansers as they may cause serious adverse effects, including electrolyte disturbances and kidney damage. While no longer indicated for use as purgatives, these products are still considered to be safe and effective for laxative use.

At the time, there were three authorized oral sodium phosphate products in Canada with instructions for laxative and purgative use on their labels. Two of the products have since been recalled and relabelled by the manufacturers with new product labels, instructions and packaging to remove the purgative indication, and are now available for sale on the Canadian market:

• Phoslax (by Odan Laboratories Ltd.; NPN 80000689), and
• Phosphates Solution (by Pharmascience Inc.; NPN 02230399). This product is also sold under the following three brand names: Option + Phosphates Solution , Pharmasave Phosphates Solution and Réservé Phosphates Solution . Option + Phosphates Solution has been relabelled and will soon be back on the market while Pharmasave Phosphates Solution and Réservé Phosphates Solution may be relabelled and available for sale at a later date.

The sale of the third product, Fleet Phospho-Soda Oral Laxative , has been voluntarily discontinued in Canada by the manufacturer, Johnson & Johnson MERCK Consumer Pharmaceuticals.

Health Canada reminds Canadians to read the new labels carefully and use these products as directed. Consumers with questions or who are concerned about symptoms possibly associated with oral sodium phosphate products should consult with their health care practitioner.

Authorized health products will bear an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) on the label. This authorization indicates that the product has been assessed by Health Canada for safety, effectiveness and quality.

Consumers requiring more information about this information update can contact Health Canada 's public enquiries line at (613) 957-2992, 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 website
• 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 website The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this website.

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Media Enquiries:
Health Canada
(613) 957-2983

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