Two years ago, nephrologists and other health care providers who attended the ASN Renal Week seminars heard talks about an emerging concern in the field. Diagnostic test preparations, such as products used to cleanse the bowel prior to colonoscopies, were identified as causing damage to the kidneys.

During the 2007 conference, Dr. Glen S. Markowitz of Columbia University provided an update on the risks of acute and chronic renal failure related to the use of oral sodium phosphate solution, also known as OSPs. This product is widely used to prepare the bowels before procedures such as colonoscopy or surgery. Dr. Markowitz point out that there was a special concern about a rare but serious type of renal failure called acute phosphate nephropathy associated with the use of OSPs.

A year after the 2007 Renal Week conference, the Food and Drug Administration (FDA), after receiving several reports of kidney injury associated with use of OSPs, issued a black box warning on prescription brands of the product, such as Visicol and Osmo Prep. Fleet, makers of over-the-counter OSP solutions, followed suit by pulling their products from store shelves.

The 2009 ASN Renal Week conference will be held in San Diego, California. The annual scientific meeting includes presentations of original research such as free communications and posters, as well as a wide array of symposia, conferences and courses on a full range of topics from basic science to clinical practice and public policy.

SOURCE: Fleet Attorney › 2009 ASN Renal Week is Oct. 27-Nov. 1

In December 2008, the Food and Drug Administration (FDA) issued a black box warning on prescription OSP products Visicol and Osmo Prep made by Salix Pharmaceuticals after numerous reports of a serious form of kidney injury known as acute phosphate nephropathy had been reported in patients following the use of the products. The FDA also expressed equal concern over the use of over-the-counter OSP solutions such as Fleet Phospho-soda and Fleet Accu-Prep. As a result of the warning, C.B. Fleet issued a recall of its over-the-counter OSP solutions.

Since the FDA issued its first alert in May 2006 about the potential risk of acute phosphate nephropathy in patients who used OSP products, steps have been taken to warn doctors of the potential risks in using OSP products. The warning also was added to a consensus document on bowel preparation issued jointly by the American Society of Colon and Rectal Surgeons, the American Society of Gastrointestinal Endoscopy, and the Society of American Gastrointestinal and Endoscopic Surgeons.

“Hopefully this will lead to increased awareness of the risk factors for (acute phosphate nephropathy) and more judicious, individualized selection of bowel purgatives,” the authors write. “Additional prospective studies are needed to more precisely determine the incidence of (acute phosphate nephropathy) so that physicians and patients can make informed decisions regarding the choice of bowel purgative.”

Source: JASN

SOURCE: Fleet Attorney › Thousands could be injured each year by OSP bowel cleansers