Yourlawyer.com (Fleet Phospho-soda Recall News)

Oral Sodium Phosphate Solution Dangers

Tue, 03 Mar 2009 00:00:00 -0800

In December, we reported that the U.S. Food and Drug Administration (FDA) had ordered the makers of Visicol and OsmoPrep to include black box warnings on the drugs’ labels regarding acute kidney risks associated with prescription sodium phosphate medications (OSPs) that many people take as a bowel prep before colonoscopy. A recent article in Public Citizen's "Worst Pills, Best Pills" newsletter pointed out that the FDA has received more reports of patients falling ill with acute phosphate nephropathy, a type of serious, acute kidney damage, associated with the use of OSPs.

The FDA said it had seen similar kidney problems in people who used over-the-counter (OTC) sodium phosphate products as bowel preps, and recommended they not be used for this purpose. The FDA said it planned to amend the labeling conditions for OTC OSP products to address this concern with bowel cleansing use. As a result, C.B. Fleet Co. announced a voluntary recall of OTC Fleet Phospho-soda products. The product is a non-prescription laxative, but is often used in larger doses for bowel cleansing.

In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of OSPs for bowel cleansing. Since, as part of the agency’s post-marketing surveillance, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep; three were biopsy-proven cases of acute phosphate nephropathy. The FDA said the onset of kidney injury in these cases varied, occurring in some within several hours of use of these products, and in other cases, up to 21 days after use.

The FDA also warned that OSPs should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate and also recommended that prescription OSPs be used with caution for bowel cleansing by people over 55 years of age; people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying; and people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure), angiotensin receptor blockers (used to treat high blood pressure and heart or kidney failure), and, possibly, nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medication

Public Citizen noted that acute phosphate nephropathy is a rare, but serious condition in which deposits of calcium-phosphate crystals are trapped in the renal (kidney) tubules and which may result in permanent kidney function impairment. There are safer, equally effective, alternatives to OSPs for pre-colonoscopy bowel cleansing which do not contain sodium phosphate, said Public Citizen. Two of the most commonly used products are Colyte and TriLyte, both oral solutions, which require a presecription, it recommended

The FDA is requiring, reported Public Citizen, the maker of Visicol and OsmoPrep to conduct a post-marketing clinical trial to further assess the risk of acute kidney injury with use of these medications and must also develop and implement a risk evaluation and mitigation strategy (REMS) that is to include a Medication Guide informing patients about the products about benefits and risks of these products.

Colonoscopy Preps, Visicol and OsmoPrep, Linked to Kidney Problems

Wed, 17 Dec 2008 00:00:00 -0800

Visicol and OsmoPrep, prescription sodium phosphate medications that many people take as a bowel prep before a colonoscopy, have been linked to acute kidney damage. The problem recently prompted the Food & Drug Administration (FDA) to order that the drugs' makers include black box warnings on their labels about kidney risks.

The FDA also said it had seen similar kidney problems in people who used over-the-counter sodium phosphate products as bowel preps, and recommended they not be used for this purpose. The FDA said it planned to amend the labeling conditions for over-the-counter OSP products to address this concern with bowel cleansing use. As a result, C.B. Fleet Co. announced a voluntary recall of over-the-counter Fleet Phospho-soda products last week. Fleet Phospho-soda is a non-prescription laxative, but it is often used in larger doses has been used for bowel-cleansing.

In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of oral sodium phosphate products for bowel cleansing. Since then, as part of the agency’s postmarketing surveillance, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep. Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The FDA said the onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use, the agency said.

The FDA also warned that oral sodium phosphate products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate. Finally, the agency recommended that oral sodium phosphate prescription products be used with caution for bowel cleansing by the following at risk groups:

people over 55 years of age,
people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and
people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medication

Fleet Phospho-soda Recall Lawyers

Wed, 17 Dec 2008 00:00:00 -0800

Fleet Phospho-soda Recall Lawyers

The lawyers / attorneys at our firm are currently offering free case evaluations to individuals who sustained kidney damage after using either Fleet Phospho-soda or the Fleet Phospho-soda EZ-Prep Bowel Cleansing System. C.B. Fleet issued a voluntary recall of the Fleet Phospho-soda products after the Food & Drug Administration (FDA) warned that over-the-counter oral sodium phosphate (OSP) products, when used at high doses, put patients at risk for acute kidney damage.

Patients routinely take OSP products, like Fleet Phospho-soda, to clean the intestines before a colonoscopy and other medical procedures. In addition to issuing a warning about over-the-counter OSPs, the FDA required the makers of two prescription varieties, Osmoprep and Visicol, to add a Boxed Warning about kidney risks to the labeling of those products.

The risk of kidney damage associated with the use of OSP products, including Fleet Phospho-soda, has been known since at least 2006. However, companies such as C.B. Fleet have failed to warn patients about these dangers. The Fleet Phospho-soda recall lawyers at our firm believe the manufacturers of these products are guilty of negligence.

If you or someone you know suffered kidney damage following the use of a recalled over-the-counter Fleet Phospho-soda products, you may be entitled to compensation. We urge you to contact one of our Fleet Phospho-soda recall lawyers right away to discuss the legal remedies available to you.

According to C.B. Fleet, the Fleet Phospho-soda recall was issued to address the FDA's determination that OSPs used for bowel preparation prior to medical procedures such as colonoscopy should only be available by prescription. The recall was issued at the retail and wholesale level only.

Prior to the recall, Fleet Phospho-soda products were currently labeled and sold as over-the-counter products. Following the FDA's recommendation that doctors not direct their patients to use these over-the-counter products for bowel cleansing, C.B. Fleet requested that consumers not purchase these products for that purpose. The company's recall notice said that patients should contact their physician for alternatives if their physician has recommended their use as a bowel prep.

FDA Warning on OSP Products and Acute Kidney Damage

In December 2008, the FDA announced it was adding a Boxed Warning to the prescription OSP products, Visicol and OsmoPrep In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of OSP products for bowel cleansing. Since then, as part of the agency’s postmarketing surveillance, the FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep.

Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use, the agency said. In addition to investigating potential product liability lawsuits against C.B. Fleet, our Fleet Phospho-soda recall lawyers are also evaluating claims involving prescription Osmoprep and Visicol.

In addition to the Boxed Warning, the FDA also required the manufacturers of prescription OSPs to develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with the use of these products.

The agency also warned about possible kidney problems with over-the-counter OSP products, such as Fleet Phospho-soda. The available data do not show a risk of acute kidney injury when these OTC products are used at a lower dose for laxative use. However, when used for bowel cleansing, these products have the same risks as prescription OSP products, the FDA said.

The FDA said it planned to amend the labeling conditions for over-the-counter OSP products to address this concern with bowel cleansing use. The FDA recommended that consumers not use over-the-counter OSPs for bowel cleansing.

The FDA also warned that OSP products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate. Finally, the agency recommended that OSP prescription products be used with caution for bowel cleansing by the following at risk groups:

· people over 55 years of age,

· people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and

· people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications).

Legal Help for Victims of Fleet Phospho-soda, Other Bowel Prep Products

If you or someone you love suffered acute kidney damage after using either a prescription or over-the-counter bowel prep, especially a recalled Fleet Phospho-soda product, you have valuable legal rights. Please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with one of our Fleet Phospho-soda recall lawyers.