Maker of bowel cleansing products and laxatives C.B. Fleet wants to sell its over-the-counter oral sodium phosphate (OSP) solutions to consumers even though the company recalled them six months ago after the Food and Drug Administration (FDA) issued black box warnings on prescription OSPs and raised serious concerns over the over-the-counter OSP products. The FDA had received numerous reports of a serious form of kidney injury known as acute phosphate nephropathy following the use of OSP.
Currently, C.B. Fleet faces 38 lawsuits that allege the pharmaceutical company did not do enough to warn consumers and health care providers of the risk of serious kidney injury when using its products. The lawsuits were consolidated last week into one federal court to speed the pretrial process.
C.B. Fleet chief scientific officer Chris McDaniel says several thousands of cases of the company’s OSP products have been returned to the company’s Lynchburg, Virginia, headquarters. The company contends that the products are still safe if used as directed, in low doses as a laxative or in higher doses for bowel cleansing prior to procedures such as colonoscopy. In larger doses, the labeling says consumers should drink at least 72 ounces of water to avoid dehydration during use over two days. It also warns individuals who had kidney problems not to use the solutions.
“Fleet’s priority is to ensure the safety of our customers and consumers in general,” McDaniel said. “… We would have to consider whether we felt comfortable that the product would be used safely and according to the labeling that we put out with the product.”
Source: The News & Advance