Wayne Wright LLP - Oral Sodium Phosphate Lawyers
OSP Attorneys Serving San Antonio, Corpus Christi, Austin, Houston, El Paso

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San Antonio Oral Sodium Phosphate Recall Lawyer

If you or a loved one has suffered injuries following the use of OSPs, you have a right to seek compensation from the drug manufacturer. Please CALL TODAY to speak to our San Antonio Oral Sodium Phosphate Recall Lawyer for complete information on your legal rights.

What is it?

Oral Sodium Phosphate (OSP) tablets have been commonly used for bowel cleansing and preparation before colonoscopy procedures. Visicol and OsmoPrep, manufactured by Salix Pharmaceuticals, are popularly available brands of prescription OSPs. In addition, OSPs are also available as over-the-counter laxatives such as Fleet Phospho-soda manufactured by C. B. Fleet Company.

OSP and Renal Injuries

In recent times, several reports have emerged on the risk of acute phosphate nephropathy, developing in patients who have used OSPs, even though they haven't had any apparent risk factors for developing the condition. Most of the patients had been perfectly healthy, had not suffered any kidney ailments, and had had no family history of renal conditions prior to their exposure to OSPs. The condition, also known as nephrocalcinosis, develops when calcium-phosphate crystals deposit in the renal tubules, causing serious and permanent injuries to the kidney. Patients with the condition may need dialysis or a kidney transplant as the condition worsens. Health professionals observe that individuals without apparent risk factors do develop the condition, if they had been dehydrated prior to the use of OSPs or had inadequate fluid intake after using the OSPs.

The FDA identifies the possibility of increased risk in individuals:

• 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 said the onset of kidney injury in these cases varied, occurring in some within several hours of use of these products, and in other cases, up to 21 days after use.

Given that the OSPs have long been used as a safe over the counter laxative, and commonly recommended in bowel cleansing procedures, the FDA has presently continued to allow their availability in the market. However, in order to minimise the risks of developing conditions such as acute phosphate nephropathy, the agency has ordered a risk evaluation and mitigation strategy from the manufacturer, by way of steps such as including a medication guide, conducting a post-marketing clinical trial to closely study the risk of renal injuries following OSP use.

Additionally, the FDA has also ordered the amendment of the professional labeling for over the counter OSPs to indicate that they shall be used for bowel cleansing procedures only when prescribed by a doctor. Currently, OSP manufacturers Visicol and OsmoPrep have been required to add Boxed Warning to the labeling on their OSP products.

Further, Fleet Laboratories which manufactures over the counter OSPs (Fleet Phospho-soda) has voluntarily recalled its product and added 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."

Citizen action group Public Citizen has noted that safer and equally effective alternatives to OSPs such as Colyte and TriLyte, are available in the market. It is disappointing to note while safer alternatives are available, giant pharmaceutical companies and manufacturers have jeopardised the health and safety of the public by marketing drugs and devices that haven't been sufficiently validated before being launched into the market.

Our San Antonio Oral Sodium Phosphate Lawsuit Attorney will work closely with you to understand and evaluate your case individually. You can expect to receive complete assistance with all legal formalities from our San Antonio Oral Sodium Phosphate Lawsuit Attorney.

Our Oral Sodium Phosphate Kidney Injury Lawyers offer expertise gained from years of rich experience in handling medico-legal cases. Contact our Oral Sodium Phosphate Kidney Injury Lawyers today at (866)761-7797 for a free consultation.