Pennsylvania Attorneys Pursuing Justice for those Injured by Oral Sodium Phosphate
Our Pennsylvania personal injury attorneys have joined forces with a nationally recognized mass tort litigation firm to help those who may have been injured by Oral Sodium Phosphate (OSP). This action is a result of the December 11th announcement by the FDA alerting that Oral Sodium Phosphate products used for bowel cleansing prior to colonoscopy or other procedures may cause acute phosphate nephropathy.
The FDA stated that they have become aware of reports of acute nephropathy, a type of acute injury, associated with the use of oral sodium phosphate products. The products include the prescription products, Visicol and OsmoPrep, and over-the-counter oral sodium phosphate products that can be used as a laxative such as Fleet Phospho-soda EZ-prep.
An interesting statement in the FDA Alert is 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." We have seen many clients who were perfectly healthy and had had no signs of kidney problems prior to their exposure to an OSP. Most of the clients we have spoken to had never had a problem with their kidneys and do not have a family history of kidney disease.
Who is at risk?
Anyone who has had a colonoscopy and has used an oral sodium phosphate product for bowel cleansing prior to the colonoscopy. According to the FDA, "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])."
The FDA is now requiring the manufacturer of Visicol and OsmoPrep to add Boxed Warning to the labeling for these prescriptions.
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."
Acute Phosphate Nephropathy
Acute phosphate nephropathy, also known as nephrocalcinosis, is a very 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.
Contact Marcus & Mack Today
Our experienced personal injury and pharmaceutical litigation attorneys at Marcus & Mack are accepting clients from across the state of Pennsylvania and beyond, who have suffered a kidney injury that may be the result of the use of an oral sodium phosphate.
Click here to read the entire FDA Alert
Free Initial Consultations - No Fee Unless You Collect
Call us at 866-527-2161(Toll Free) day or night, or contact a product liability lawyer via e-mail for a free case evaluation.
Let Us Help You Get the Compensation You Deserve For Your Injury
Marcus & Mack | Pennsylvania Workers Compensation Attorneys
24 Hour Personal Injury Hotline at 1-866-527-2161
