When the Food and Drug Administration (FDA) issued a black box warning on prescription oral sodium phosphates (OSP) Visicol and Osmo Prep, medications used to clear the bowel before colonoscopies and other procedures, C.B. Fleet also removed its over-the-counter OSP solutions from store shelves. While safe when used in low doses as a laxative, those products, known over-the-counter by such brand names as Fleet Phospho-soda and Fleet Accu-Prep, when used in higher doses for bowel cleansing, have been linked to a serious form kidney injury called acute phosphate nephropathy. Despite the warnings issued here in the U.S., the products are still widely available in countries like Jamaica.
According to the Jamaica Observer, several pharmacies still carry the over-the-counter products. Sources within the Ministry of Health say that the decision not to recall the drug in that country is likely because the over-the-counter OSPs are regulated as a “pharmacy only” drug, meaning they should only be sold under the supervision of a registered pharmacist. Reporters checked several pharmacies and noticed the procedure was not in place and that the solutions were widely available outside the pharmacies’ dispensaries.
Facey Commodity Ltd., Jamaican distributors of Fleet OSP products, says Fleet’s recall of its OSP products was not a worldwide recall. “The reason for that recall was that it was readily available and easily accessible to all and sundry in the States. It was being sold over-the-counter,” a Facey Commodity Ltd. spokesperson told the newspaper. “The difference is that here, according to the registration, it is only sold by pharmacists. It’s not registered in the island to be sold outside the dispensary.”
C.B. Fleet has asked that consumers there not purchase the products for bowel cleansing but to consult with their physicians for alternatives.