Fleet OSP Bowel Cleansing Phospho-soda Recall
The FDA is announcing new safety measures for oral sodium phosphate (OSP) products used for bowel cleansing before colonoscopies and other procedures. These products are associated with acute phosphate nephropathy, a rare but serious type of kidney injury or renal failure. The events have been reported with the prescription products Visicol and OsmoPrep, and also over-the-counter sodium phosphate products when they are used as bowel cleansers.
FDA believes that oral sodium phosphate products should be available only by prescription when they are used for bowel cleansing. Because of this, C.B. Fleet Company has voluntarily recalled the company's oral sodium phosphate (OSP) products sold over the counter, (Fleet Phospho-soda and Fleet EZ-PREP) and has advised healthcare professionals not to instruct patients to use these products for bowel cleansing. Unico Holdings, Inc. is also recalling its OTC oral sodium phosphate products sold for bowel cleansing. A potential Fleet class action lawsuit may take place and may offer victims cash settlements.
FDA first warned about this problem in 2006, but cases of kidney injury continue to be reported. So FDA is requiring the manufacturer of Visicol and OsmoPrep to take several steps. First, a boxed warning about the risk of acute phosphate nephropathy will be added to the product label. The manufacturer will also conduct a new clinical trial to further study the risk of acute kidney injury with these products, provide a Medication Guide for patients, and implement a risk evaluation and mitigation strategy to ensure that the benefits of using these products outweigh their risks.
Health professionals should use caution when prescribing Visicol or OsmoPrep for patients who may be at higher risk of kidney injury. This includes those over aged 55, or those who have kidney disease, bowel obstruction, active colitis, or are dehydrated. It also includes patients taking drugs that affect renal perfusion or function such as diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs) and possibly NSAIDS.
Prescribers should instruct patients about how to prepare for their procedures, and tell them to avoid dehydration by drinking enough clear liquids before, during and after bowel preparation. They should also tell patients to be alert for symptoms of acute kidney injury, including malaise, lethargy, drowsiness, decreased urine volume and swelling of the ankles, feet and legs.
Additional Information on Oral Sodium Phosphates:
FDA MedWatch Safety Alert. Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription).
C.B. Fleet Company Press Release. C.B. Fleet Voluntarily Recalls its Fleet Phospho-soda Product after FDA Safety Alert.
One of the leading lines of products that has come about in recent years in conjunction with this health issue is known as Oral Sodium Phosphate (OSP). OSP’s are products that patients are supposed to use prior to colon procedures that are meant to cleans the bowels and remove any obstructions that could complicate these procedures.
Generally, these products are taken orally the day before a colon exam, and several companies have generated millions of dollars in revenue as a result of marketing these OSP’s. Unfortunately, several OSP’s have come under scrutiny due to a link to the development of renal (kidney) failure after using them.
Brand names of OSP's that have drawn intense fire include:
- Fleet Phospho-soda
Bowel Cleansing Products Linked to Renal Failure.
Specifically, these products have shown a tendency to deposit calcium-phosphate crystals in renal (kidney) tubules cause acute phosphate nephropathy. This condition is very dangerous, painful and severe, and if it’s not diagnosed and treated quickly it can lead to total renal failure. If renal failure is not properly treated, it can quickly lead to the death of a patient.
There is a specific group of people who appear to be the most at-risk of developing this condition, and they include:
- Patients over the age of 55
- Those who already suffer from bowel obstruction
- Those with active colitis and baseline kidney disease
- Patients already using medication that affects kidney function.
Common symptoms of phosphate nephropathy include:
- Decreased urine
- Swelling of lower extremities
Perhaps the most daunting aspect of this situation is that it can take up to three weeks for the damage done by OSP’s to appear in the form of outward symptoms.
FDA Warning on OSP's
In December of 2008, the FDA issued a public warning regarding the link between OSP’s and this condition. While no known statistics exist in regards to the number of people harmed by using these products, if you or someone you love has suffered as a result of using any of them, you need to contact our Fleet OSP attorneys as soon as possible to schedule a free initial consultation.