Advisory

2002-22
April 4, 2002

Important safety information for patients taking sodium phosphates oral solutions (Fleet®, Phospho-soda® and Phosphates Solution)

OTTAWA - Health Canada, following a review of current national and international safety information and medical literature, is advising Canadians of some new safety concerns related to sodium phosphates oral solutions. Two of these products, Fleet® Phospho-soda® (marketed by Johnson & Johnson - MERCK Consumer Pharmaceuticals) and Phosphates Solution (marketed by Pharmascience Inc.), are available in Canada.

Sodium phosphates oral solutions are used as laxatives and as bowel cleansers before X-ray examinations, colonoscopy, and surgery. These solutions are taken orally and can cause dehydration and changes in the levels of calcium, phosphorus, potassium, and sodium (known as electrolytes) in the blood when used inappropriately. These changes can affect the function of the heart, muscles, and kidneys. The maximum recommended dose of oral sodium phosphates solution for an adult is 45 mL in a 24-hour period.

Some patients are at greater risk for developing electrolyte changes with these drugs, such as those suffering from kidney failure, heart disease, bowel disease, diarrhea, vomiting, those taking drugs that can affect electrolyte levels, such as diuretics; and the elderly. Patients with or without these risk factors are also at increased risk if they take more than the maximum recommended dose of 45 mL of sodium phosphates oral solution in a 24-hour period. Patients are advised to discuss their medical history with their physician before taking these products, and should seek medical attention immediately if they experience symptoms of electrolyte changes such as tingling skin, numbness, spasms, muscle weakness, tremors, and palpitations when taking sodium phosphates oral solution.

This advisory is in addition to letters sent to health care professionals by the manufacturers of Fleet® Phospho-soda® and Phosphates Solution reminding them of the above mentioned safety concerns, following discussions with Health Canada. Health Canada will continue to review the safety profile of sodium phosphates oral solutions and will advise the public of any further regulatory action.

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Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991