Our lawyers are now looking at potential class action cases involving oral sodium phosphate products. The FDA stated in December, through a MedWatch Safety Alert, that oral sodium phosphates (OSP) bowel cleansing solutions should be available by prescription only.
The MedWatch Safety Alert, with the cumbersome title, “Oral Sodium Phosphate (OSP) Products for Bowel Cleansing: reports of acute phosphate nephropathy, Boxed Warning to be added to labeling,” reported serious kidney injuries were associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to not only colonoscopies but other less invasive procedures. MedWatch also noted something that will be critical in proving these lawsuits: they have found kidney injuries in patients who not only had no prior kidney injury but also had no markers that would make them candidates for this particular kidney injury (acute phosphate nephropathy).
Acute phosphate nephropathy, often called acute nephrocalcinosis, is a very serious kidney injury that can require dialysis or a kidney transplant and can lead to acute renal failure and even death.
The FDA is also concerned with all potential kidney injuries and risks associated with the use of OSP products available over-the-counter (OTC). The reason the OTC problem is more severe is that the injury appears to be dose-responsive.
The potential risks associated with these OSP medications are not a new development. In 2006, the FDA issued a Science Paper and a Healthcare Professional sheet setting forth the risks associated with the use of OSP products for bowel cleansing. After this paper, the FDA received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep.
How many total cases are there? I don’t think the doctors who are in the middle of all of this, much less the lawyers, have a clue. But according to the Food and Drug Administration (FDA), there are already 21 apparent cases of acute phosphate nephropathy in patients who used an OSP as a bowel cleanser prior to colonoscopy or colon-rectal surgery.
In response to the FDA’s alert, one manufacturer, C.B. Fleet Company, immediately announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® BowelCleansing System. They are to be commended for moving quickly after the FDA Alert, but the question remains: what took them so long?