Oral sodium phosphate products are no longer authorized for purgative use - For Health Professionals

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Contact: Marketed Health Products Directorate (MHPD)

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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Pharmascience Inc. and Odan Laboratories Ltd. Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on Oral Sodium Phosphate Products

July 28, 2009

Subject: Oral sodium phosphate products are no longer authorized for purgative use

Dear Health Care Professional,

Pharmascience Inc. and Odan Laboratories Ltd., in consultation with Health Canada, would like to inform prescribers of important new safety information regarding the use of oral sodium phosphate products.

In Canada, oral sodium phosphate products are regulated as natural health products. These products have actions as a laxative and a purgative, and have been used for the relief of constipation and for preparing the bowel for medical and surgical procedures. Phosphates Solution by Pharmascience Inc. (NPN 02230399) and Phoslax by Odan Laboratories Ltd. (NPN 80000689) were formerly authorized for both laxative and purgative use. Phosphates Solution is also sold under the brand names Option + Phosphates Solution, Pharmasave Phosphates Solution and Réservé Phosphates Solution.

Oral sodium phosphate products have a long history of safe use as laxatives, but when taken for purgative use they have been associated with serious adverse effects, including electrolyte disturbances and kidney injury. Health Canada received 54 adverse reaction reports in association with oral sodium phosphate products, of which 31 case reports involved kidney dysfunction, including 28 reported as serious. Other adverse reactions included gastrointestinal symptoms, cardiovascular and neurological problems, and allergic reactions. 

Following a review of the available evidence, including the domestic adverse reaction reports, Health Canada warned Canadians on March 5, 2009, not to use oral sodium phosphate products as purgatives, unless recommended by a health care practitioner, as they may cause serious adverse effects.

Pharmascience Inc. and Odan Laboratories Ltd. have worked with Health Canada to take appropriate actions to reduce risk and ensure the health and safety of Canadians:

• authorized over-the-counter oral sodium phosphate products are no longer indicated for purgative use; 
• a stop sale and recall to the retail level of products with the purgative indication has been completed;
• Pharmascience Inc. and Odan Laboratories Ltd. have developed new labels and boxes that do not include instructions for purgative use; and
• Phosphates Solution and Phoslax are now available for sale with the revised labeling indicating the products' use as laxatives solely; Option + Phosphates Solution will soon be back on the market while Pharmasave Phosphates Solution and Réservé Phosphates Solution may be available for sale at a later date.

Pharmascience Inc. previously issued risk communications related to the safe use of oral sodium phosphate products, including a Dear Health Care Professional Letter in December 2005 entitled "Health Canada Endorsed Important Safety Information on Phosphates solution (oral sodium phosphates)".

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any occurrence of serious and/or unexpected adverse reactions in patients taking an oral sodium phosphate product should be reported to the appropriate company or Health Canada at the following addresses:

For PHOSPHATES SOLUTION:
Medical Information Dept.
Pharmascience Inc.
6111 Royalmount Ave.
Montreal, Quebec H4P 2T4
Telephone: 514-344-0764 or 1-888-550-6060
Fax: 514-340-0164
E-mail: adr@pharmascience.com

For PHOSLAX:
Medical Information Dept.
Odan Laboratories Ltd.
325 Stillview Avenue
Pointe-Claire, Quebec H9R 2Y6
Telephone: 514-428-1628 or 1-800-387-9342
Fax: 514-428-9783 or 1-800-329-6326
E-mail: info@odanlab.com

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

original signed by

Vlad Kurktschi
Vice-President Quality
Pharmascience Inc.

original signed by

David Kaminsky
Vice-President Corporate
Odan Laboratories Ltd.