Bowel Cleansing Product Recalled Amid Continuing Reports of Serious Side Effects

For several years, people have been using different products to cleanse their bowels in preparation for colon procedures, most commonly colonoscopies. These products have generally been marketed as easy to use, convenient and painless, and for a time they grew in prevalence. However, recent reports have arisen that have prompted one of the leading manufacturers of these bowel prep products to initiate a voluntary recall until additional studies can be completed that assess the risks involved with using them.

The company that’s executing the recall is C.B. Fleet Co., and the products that are subject to the recall are known to consumers as Fleet Phospho-soda or the Fleet Phospho-soda EZ-Prep Bowel Cleansing System. The issues surrounding these and other products are detailed below, but if you have been harmed as a result of using any bowel prep product, contact the dangerous products attorneys at Parilman & Associates today to schedule a free initial consultation.

Bowel Cleansing Products

Bowel cleansing products are known scientifically as ‘OSP’s,’ which means sodium phosphate medications. OSP’s are sold both by prescription and over the counter, and their purpose is to remove excess materials from the bowel so that doctors can more effectively perform colon procedures, with colonoscopies the most common among them.

The Problems

The scrutiny that befell these products came as a result of mounting reports of people using OSP’s developing serious side effects anywhere from hours after they were used to weeks afterward. Additionally, investigations discovered that patients with certain preexisting conditions were more prone to these side effects, and these conditions included:
• Dehydration
• Kidney disease
• Acute colitis

The side effects also showed themselves to be more likely with people taking certain medications that affect kidney function, such as:
• Diuretics
• Angiotensin converting enzyme inhibitors
• Angiotensin receptor blockers
• Nonsteroidal anti-inflammatory drugs

Reports have also indicated that patients under the age of 18 and over the age of 55 were particularly vulnerable to unforeseen medical problems. In terms of the side effects, patients were shown to be vulnerable to kidney damage, and most prominently a rare condition known as acute phosphate nephropathy. This condition is an extremely dangerous health problem that tends to lead to deposits of calcium-phosphate crystals becoming trapped in the renal (kidney) tubules. This entrapment of these crystals can lead to permanent kidney function impairment.

Acute phosphate nephropathy tends to present itself with any of the following symptoms:

• Malaise
• Lethargy
• Drowsiness
• Decreased amount of urine
• Swelling of the ankles, feet and legs

While any of these symptoms may present themselves immediately, none are immediately associated with acute phosphate nephropathy automatically. Generally, this condition will only be diagnosed early in its cycle by way of blood tests and other relatively meticulous medical tests.

The FDA’s Role in the OSP Issue

The US Food and Drug Administration (FDA) has been deeply involved in this OSP issue for more than a year now, and it’s taken several steps to ensure that proper tests and investigations are done that provide the public with enough data to make a sound decision regarding the safety versus the risk of using these products. Below is a brief chronological look at how the FDA has acted in response to the OSP issue.

1. 2006 – The FDA issued a Science Paper and a Healthcare Professional sheet describing the risks associated with the use of OSP’s for bowel cleansing. When the FDA issues such a document, it monitors the products on a continual basis. During the time that followed the issuance of this document, 20 additional cases of patients using OSP’s and developing kidney problems surfaced.
2. December of 2008 – The FDA responded to continuing reports of side effects on its own Web site with the following statement:

“FDA is requiring the manufacturer of the prescription drugs Visicol and OsmoPrep to strengthen the product labeling to include a boxed warning, provide a Medication Guide for patients, and implement a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the products outweigh the risk of acute phosphate nephropathy, a type of acute kidney injury. FDA is also requiring that a post marketing clinical trial be conducted to further assess the risk of acute kidney injury with use of these products.”

After the steps had been taken subsequent to the FDA statement, C.B. Fleet Co. announced the voluntary recall of the products mentioned above.

How to Proceed

As can be seen, OSP’s can be dangerous for some people, and this includes both the over-the-counter (OTC) options and those only given by prescription. If you have been harmed as a result of using OSP’s in preparation for a colon procedure, you need to contact the dangerous drugs lawyers at Parilman & Associates today to schedule a free initial consultation.