Canada orders makers of common OTC laxatives to re-label

Health Canada has ordered manufacturers of over-the-counter oral sodium phosphates (OSP), such as Fleet Phospho-Soda, to either re-label the products to remove any mention of bowel cleansing, or remove the products completely from the Canadian market.

The move follows a U.S. Food and Drug Administration (FDA) investigation into OSPs, products commonly used to cleanse the bowel before colonoscopies, which found people who use the products were at greater risk of suffering from a serious kidney injury known as acute phosphate nephropathy. The investigation resulted in black box warnings on prescription OSP brands, Visicol and Osmo Prep. And, C.B. Fleet voluntarily recalled its over-the-counter OSP products as well.

Health Canada’s warning is a result of more than 50 “adverse reactions” from people who used OSP products and suffered electrolyte disturbances, kidney injury, gastrointestinal symptoms, cardiovascular and neurological problems, or allergic reactions.

Health Canada says the over-the-counter OSPs are considered safe when used in lower doses to treat constipation, and thus can still be sold in Canada as long as the label does not list using the medication at higher doses for bowel cleansing.

Products in question include Phoslax, Fleet Phospho-Soda Oral Laxative, and Phosphate Solution, also sold under the brand names Option + Phosphates Solution, Pharmasave Phosphates Solution and Reserve Phosphates Solution. Fleet Phospho-Soda Oral Laxative has been voluntarily discontinued in Canada by the manufacturer. Option + Phosphates Solution has been re-labeled and will soon be back on the market. Pharmasave Phosphates Solution and Reserve Phosphates Solution may soon be re-labeled and available to consumers at a later date.