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New Gender Risk Factors Associated With Oral Sodium Phosphates

In a recent turn of events, the U.S. Food and Drug Administration (FDA) acknowledged critical, previously unknown risk factors associated with the use of oral sodium phosphates (OSP’s). Recent evidence lends weight to the long-suspected link between OSP medications and acute phosphate neuropathy, but researchers have discovered significant risk factors that are not currently indicated on the labeling of OSP products. More specifically, females and those with low body weight who undergo OSP treatment, may significantly increase their risk of developing acute phosphate neuropathy.

Oral sodium phosphate medications, such as OsmoPrep, Fleet Phospho-soda and Visicol, are intended to assist in the process of bowel cleansing. OSP is administered to completely empty the colon before a number of endoscopic procedures. In particular, doctors will prescribe OSP medications before colonoscopies in order to preform a proper and unobstructed examination of the colon and the distal part of the small bowel.

Unfortunately, recent evidence suggests that the mechanism regarding the association between bowel preparation agents and acute phosphate neuropathy may be directly related to the pharmacodynamics of oral sodium phosphates. In a retrospective study conducted by researchers at NorthShore University Health System in Evanston, researchers analyzed the risk of adverse renal events associated with the use of oral sodium phosphate tablets.

The study, which was titled Renal risks of sodium phosphate tablets for colonoscopy preparation: A review of adverse drug reactions (ADRs) reported to the Food and Drug Administration (FDA), utilized over two million files from the FDA’s Adverse Event Reporting System (AERS). In a time frame ranging from 2004 to 2009, researchers acknowledged that, in 178 cases dealing with bowel preparation agents (71 % females), the adverse renal drug reactions increased each year.

As a result, researchers discovered risk factors associated with the use of OSP’s that had, until now, gone unknown. The study firmly acknowledges a significant association between adverse renal drug reactions from oral sodium phosphates in females with low body weight. More specifically, women being treated with OSP’s who have a lower than average body weight, may significantly increase their risk of developing severe renal complications such as acute phosphate neuropathy.

Acute phosphate nephropathy is a severe kidney injury which has the potential to develop within a few hours or up to 21 days after the use of oral sodium phosphates such as OsmoPrep or Visicol. An injury such as this is characterized by deposits of calcium-phosphate crystals that develop in the renal tubules. In the event that these calcium-phosphate crystals develop, kidney functions may be severely impaired. OSPs may cause acute phosphate nephropathy due to dehydration, decreased intravascular volume, and hyperphosphatemia, all of which increase phosphate levels in the renal tubules. If neglected or discovered too late, acute phosphate neuropathy may prove fatal to those diagnosed with it. Due to the severity of acute phosphate neuropathy, patients may contact an oral sodium phosphate lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential oral sodium phosphate lawsuit.

The current labeling for OSP products does not identify gender (females) and low body weight as independent risk factors associated with acute phosphate neuropathy. As a result, the companies that develop these products have demonstrated a gross neglect for consumer safety.

Do I Have an Oral Sodium Phosphate Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in oral sodium phosphate lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by an oral sodium phosphate, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

Categories: Product Liability
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