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Oral Sodium Phosphates-Visicol
Visicol®, OsmoPrep® and OSP Injury and Fatality Alert
What are OSP’s, Visicol® and OsmoPrep®?
Oral Sodium Phosphates, OSP’s, are oral medications used for bowel cleansing as preparation for a colonoscopy or other gastroenterological procedures. Visicol® and OsmoPrep® are available only by a doctor’s prescription. Both Visicol® and OsmoPrep® are manufactured and sold by Salix Pharmaceuticals of Morrisville, North Carolina. Non-prescription OSP’s include Fleet Phospho Soda E-Z Prep Bowel Cleansing System and Fleet Phospho-Soda Oral Saline Laxative
What health risks are associated with OSP’s?
The US Food and Drug Administration, the FDA, is the federal agency charged with monitoring the safety of medications. They have received an increasing number of reports of acute phosphate nephropathy developing after patients used oral sodium phosphate products (OSP’s). Patients had used the OSP’s for bowel cleansing in preparation for colonoscopy. Acute phosphate nephropathy is severe injury to the kidney, in which deposits of calcium-phosphate crystals in the tubules, the tiny tubes that comprise much of the kidney. These crystals may cause irreversible and permanent damage to the kidneys. This very serious disorder has been seen to occur in patients who have no current kidney disease or malfunction, and no known risk factors that would increase the likelihood of developing a sudden-onset severe kidney disorder.
Serious side effects of kidney failure can include mental confusion and seizures. Patients who develop Acute Phosphate Nephropathy (APN) suffer irreversible kidney damage, and may require kidney dialysis for the rest of their lives.
On December 11 2008 the FDA announced that it had ordered a Black Box Warning, its most serious caution, for both Visicol® and OsmoPrep®. Here is the text of the Black Box Warning, which must now be displayed on all prescribing literature for these medications:
There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with age 55 years and above, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, Angiotensin converting enzyme ACE] inhibitors, Angiotensin receptor blockers ARBs], and possibly nonsteroidal anti-inflammatory drugs NSAIDs]).
On December 12 2008, Fleet Laboratories announced that it has initiated a voluntary recall of Fleet Phospho Soda E-Z Prep and Fleet Phospho-Soda Oral Saline laxative. It has also notified doctors and other healthcare professionals that they should stop directing patients to use these products.
What should you do if you have used an OSP?
If you have any symptoms that you feel may be related to your to your use of OsmoPrep®, Visicol®, or any non-prescription (Over the Counter) OSP, you should immediately consult with your physician, and follow whatever course of action your doctor recommends.
Should you contact an attorney?
If you or a loved one used Visicol®, or OsmoPrep® or any non-prescription (Over the Counter) OSP, and you have been diagnosed with APN or have suffered serious symptoms that you feel may be related to the drug, you should immediately contact an attorney who handles dangerous drug cases for review of a potential claim against the manufacturer. There are deadlines set by laws which regulate the filing of lawsuits called statutes of limitation, which vary state by state. If you know that you or a loved one was harmed by Visicol® or OsmoPrep®, or a Fleet OSP product you should not delay in contacting an attorney. If the statute of limitations expires, your right to pursue a claim against the manufacturer may be forever barred.
How can Casey Gerry help you with a Visicol®, OsmoPrep® or other OSP case?
Casey Gerry, based in San Diego, is one of the oldest and most respected plaintiffs and personal injury firms in California. Our dangerous drug attorneys have worked actively in a number of major nationwide pharmaceutical and medical device cases, including Fen-Phen, Baycol, Rezulin, Propulsid, Metabolife 356, Phenylpropanolamine ("PPA"), and Guidant pacemakers/defibrillators. Casey Gerry’s team of experienced pharmaceutical lawyers is currently evaluating claims on behalf of individuals from around the United States who have suffered serious harm from using Visicol® or OsmoPrep®.
If you or a loved one has been injured as a result of using Visicol®, OsmoPrep®, or Fleet Phospho Soda E-Z Prep Bowel Cleansing System, or Fleet Phospho-Soda Oral Saline Laxative please contact us immediately for evaluation by an experienced dangerous drug attorney.
What are OSP’s, Visicol® and OsmoPrep®?
Oral Sodium Phosphates, OSP’s, are oral medications used for bowel cleansing as preparation for a colonoscopy or other gastroenterological procedures. Visicol® and OsmoPrep® are available only by a doctor’s prescription. Both Visicol® and OsmoPrep® are manufactured and sold by Salix Pharmaceuticals of Morrisville, North Carolina. Non-prescription OSP’s include Fleet Phospho Soda E-Z Prep Bowel Cleansing System and Fleet Phospho-Soda Oral Saline Laxative
What health risks are associated with OSP’s?
The US Food and Drug Administration, the FDA, is the federal agency charged with monitoring the safety of medications. They have received an increasing number of reports of acute phosphate nephropathy developing after patients used oral sodium phosphate products (OSP’s). Patients had used the OSP’s for bowel cleansing in preparation for colonoscopy. Acute phosphate nephropathy is severe injury to the kidney, in which deposits of calcium-phosphate crystals in the tubules, the tiny tubes that comprise much of the kidney. These crystals may cause irreversible and permanent damage to the kidneys. This very serious disorder has been seen to occur in patients who have no current kidney disease or malfunction, and no known risk factors that would increase the likelihood of developing a sudden-onset severe kidney disorder.
Serious side effects of kidney failure can include mental confusion and seizures. Patients who develop Acute Phosphate Nephropathy (APN) suffer irreversible kidney damage, and may require kidney dialysis for the rest of their lives.
On December 11 2008 the FDA announced that it had ordered a Black Box Warning, its most serious caution, for both Visicol® and OsmoPrep®. Here is the text of the Black Box Warning, which must now be displayed on all prescribing literature for these medications:
There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with age 55 years and above, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, Angiotensin converting enzyme ACE] inhibitors, Angiotensin receptor blockers ARBs], and possibly nonsteroidal anti-inflammatory drugs NSAIDs]).
On December 12 2008, Fleet Laboratories announced that it has initiated a voluntary recall of Fleet Phospho Soda E-Z Prep and Fleet Phospho-Soda Oral Saline laxative. It has also notified doctors and other healthcare professionals that they should stop directing patients to use these products.
What should you do if you have used an OSP?
If you have any symptoms that you feel may be related to your to your use of OsmoPrep®, Visicol®, or any non-prescription (Over the Counter) OSP, you should immediately consult with your physician, and follow whatever course of action your doctor recommends.
Should you contact an attorney?
If you or a loved one used Visicol®, or OsmoPrep® or any non-prescription (Over the Counter) OSP, and you have been diagnosed with APN or have suffered serious symptoms that you feel may be related to the drug, you should immediately contact an attorney who handles dangerous drug cases for review of a potential claim against the manufacturer. There are deadlines set by laws which regulate the filing of lawsuits called statutes of limitation, which vary state by state. If you know that you or a loved one was harmed by Visicol® or OsmoPrep®, or a Fleet OSP product you should not delay in contacting an attorney. If the statute of limitations expires, your right to pursue a claim against the manufacturer may be forever barred.
How can Casey Gerry help you with a Visicol®, OsmoPrep® or other OSP case?
Casey Gerry, based in San Diego, is one of the oldest and most respected plaintiffs and personal injury firms in California. Our dangerous drug attorneys have worked actively in a number of major nationwide pharmaceutical and medical device cases, including Fen-Phen, Baycol, Rezulin, Propulsid, Metabolife 356, Phenylpropanolamine ("PPA"), and Guidant pacemakers/defibrillators. Casey Gerry’s team of experienced pharmaceutical lawyers is currently evaluating claims on behalf of individuals from around the United States who have suffered serious harm from using Visicol® or OsmoPrep®.
If you or a loved one has been injured as a result of using Visicol®, OsmoPrep®, or Fleet Phospho Soda E-Z Prep Bowel Cleansing System, or Fleet Phospho-Soda Oral Saline Laxative please contact us immediately for evaluation by an experienced dangerous drug attorney.
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