OSP products include the prescription brands Visicol and Osmo Prep, as well as OTC brands including Fleet Phospha-soda. Over-the-counter OSP products are considered safe if used in low doses to treat constipation. But Fleet began marketing the product in higher doses as a bowel cleanser, which prompted the same risk of kidney damage and the form of kidney injury known as acute phosphate nephropathy.

OSPs work by pulling fluid from the body and out the colon, causing a laxative effect. While the body is purging itself of fluids, calcium-phosphate crystals can form in the kidneys, blocking the renal tubes. Symptoms of OSP-related kidney damage can come immediately or take as long as a few days or few weeks to surface. These symptoms include lethargy, drowsiness, decreased urine output, and swelling of the legs, ankles and feet. Often, the diagnosis isn’t immediately linked to use of OSP.

To date, more than 50 lawsuits have been filed against Fleet by people who suffered kidney injury from use of OSPs, including one recently settled in Virginia in which the lone plaintiff was awarded $10 million.

SOURCE: Fleet Attorney › Lawsuits mount against maker of over-the-counter bowel cleanser

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

SOURCE: Fleet Attorney › C.B. Fleet wants to put recalled products back on market