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05-05-2006, 10:05 AM
FDA ALERT [5/2006]: A rare, but serious form of kidney failure has been associated with the use of oral sodium phosphate (OSP) products (e.g., Fleet Phospho-soda solution, Fleet Accu-Prep solution, and Visicol tablets) for bowel cleansing. No cases of kidney failure have been associated with a recently approved OSP product (OsmoPrep tablets) for bowel cleansing.
This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.
This is a summary of the most important information about oral sodium phosphate (OSP) bowel cleansing products. For details, talk to your healthcare professional.
What Are OSP Bowel Cleansing Products?
Bowel cleansing products are used to clean the stool out of your bowel before certain medical procedures, like colonoscopy.
Who Is at Most Risk for Kidney Failure with Use of OSP Bowel Cleansing Products?
You are at increased risk of developing kidney failure with the use of OSP bowel cleansing products if you have any of the following conditions:
Heart failure
Previous kidney problems
Are elderly
Are taking certain medications that affect kidney function
What Are The Risks?
The following list includes the most common risks and side effects of OSP therapy. However, this list is not complete.
Dehydration – tell your doctor if have vomiting, dizziness, or are urinating less often than normal. This is a sign that you have lost too much fluid while using OSP. Tell your doctor if you are having trouble drinking liquids during your bowel cleansing
Abdominal (belly) pain or bloating
Nausea
Vomiting
Headache
Dizziness
What Should I Tell My Healthcare Professional?
Before you use OSP bowel cleansing products, tell your healthcare professional if you:
Are on a low salt diet
Use a diuretic (fluid pill), medicine for high blood pressure, or medicine for arthritis
Use medicine for heart problems or seizures
Have used a laxative for constipation in the past week
Have a history of kidney problems
Are pregnant or nursing a baby
Can Other Medicines Or Food Affect OSP Bowel Cleansing Products?
OSP bowel cleansing products and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how OSP bowel cleansing products work. Also, OSP bowel cleansing products may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional.
What Else Should I Know About OSP Bowel Cleansing Products?
Bowel cleansing products work by causing you to loose large amounts of fluid through your bowel movements. Frequent, loose and liquid bowel movements are expected. It is very important that you replace this fluid to prevent dehydration. Drinking large amounts of clear liquids helps you replace the fluid you lose and helps clean your bowel for your procedure. Talk to your doctor about what you can drink to help lessen the chance of becoming dehydrated while using the OSP bowel cleansing products.
This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.
This is a summary of the most important information about oral sodium phosphate (OSP) bowel cleansing products. For details, talk to your healthcare professional.
What Are OSP Bowel Cleansing Products?
Bowel cleansing products are used to clean the stool out of your bowel before certain medical procedures, like colonoscopy.
Who Is at Most Risk for Kidney Failure with Use of OSP Bowel Cleansing Products?
You are at increased risk of developing kidney failure with the use of OSP bowel cleansing products if you have any of the following conditions:
Heart failure
Previous kidney problems
Are elderly
Are taking certain medications that affect kidney function
What Are The Risks?
The following list includes the most common risks and side effects of OSP therapy. However, this list is not complete.
Dehydration – tell your doctor if have vomiting, dizziness, or are urinating less often than normal. This is a sign that you have lost too much fluid while using OSP. Tell your doctor if you are having trouble drinking liquids during your bowel cleansing
Abdominal (belly) pain or bloating
Nausea
Vomiting
Headache
Dizziness
What Should I Tell My Healthcare Professional?
Before you use OSP bowel cleansing products, tell your healthcare professional if you:
Are on a low salt diet
Use a diuretic (fluid pill), medicine for high blood pressure, or medicine for arthritis
Use medicine for heart problems or seizures
Have used a laxative for constipation in the past week
Have a history of kidney problems
Are pregnant or nursing a baby
Can Other Medicines Or Food Affect OSP Bowel Cleansing Products?
OSP bowel cleansing products and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how OSP bowel cleansing products work. Also, OSP bowel cleansing products may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional.
What Else Should I Know About OSP Bowel Cleansing Products?
Bowel cleansing products work by causing you to loose large amounts of fluid through your bowel movements. Frequent, loose and liquid bowel movements are expected. It is very important that you replace this fluid to prevent dehydration. Drinking large amounts of clear liquids helps you replace the fluid you lose and helps clean your bowel for your procedure. Talk to your doctor about what you can drink to help lessen the chance of becoming dehydrated while using the OSP bowel cleansing products.