The FDA has issued an alert that Oral Sodium Phosphate (OSP) products used for bowel cleansing before a colonoscopy or other procedures may cause acute phosphate nephropathy, a type of kidney injury.
Oral Sodium Phosphate products include the prescription products Visicol and OsmoPrep and the over-the-counter OSP product Fleet Phospho-soda EZ-prep, which can be used as a laxative.
An attorney at the Law Offices of Jeff Martin, serving all of Oklahoma, can help if you or a loved one has suffered an adverse effect from an OSP product. Our firm aggressively fights to protect the legal rights of clients who have been injured by any dangerous drug.
Reports have linked OSP to acute phosphate nephropathy, also known as nephrocalcinosis. This is a serious kidney injury associated with the deposits of calcium-phosphate crystals in the renal tubes that can require a patient to need dialysis or a kidney transplant. In the most severe cases, acute phosphate nephropathy can lead to acute renal failure and even death.
The FDA stated in its alert that "in some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for acute kidney injury."
In other words, people taking OSP may be at risk for suffering from kidney injuries, even if they had no problems with their kidneys and do not have a family history of kidney disease.
The FDA states that "individuals with an increased risk of acute phosphate nephropathy following the use of oral sodium phosphate (OSP) products include those who are over the age of 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications 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])."
Because of the risk of kidney injury, the FDA requires the manufacturer of Visicol and OsmoPrep to include the agency's strongest warnings — "black box warnings" — on their labels.
On the same day as the FDA alert, Fleet Laboratories voluntarily recalled its over-the-counter Phospho-soda products. Fleet issued a statement that "the recall decision was made to address the FDA's determination that oral sodium phosphate solutions used for bowel preparation prior to medical procedures such as colonoscopy should be available by prescription, and consumers should not be using over the counter products for bowel cleansing."
Contact the Law Offices of Jeff Martin, serving all of Oklahoma. An experienced Oral Sodium Phosphate lawyer can help if you feel that you or a loved one has been injured by an Oral Sodium Phosphate medication. Remember, your initial consultation is free, and you don't pay unless you win. Call us today in Tulsa area at 728-8888 or use our toll free number 800-980-9205.
