A large number of colonoscopy patients have suffered from serious kidney damage (acute phosphate nephropathy) after using OsmoPrep bowel cleansing product. Given the serious nature of the injuries consumers were reporting, in 2008 the FDA required a black box warning be added to the labeling of this product.
If you or a loved one has been injured by OsmoPrep, you should contact our lawyersimmediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
What is OsmoPrep used for?
OsmoPrep is an oral medication used for bowel cleansing as preparation for a colonoscopy or other gastroenterological procedure. It is manufactured and sold by Salix Pharmaceuticals and available by prescription only. Unfortunately, the U.S. Food & Drug Administration (FDA) has received an increasing number of reports of acute phosphate nephropathy and other extremely serious side effects developing after patients used oral sodium phosphate products (OSPs) like OsmoPrep.
OsmoPrep & Acute Phosphate Nephropathy
Acute phosphate nephropathy is a form of kidney injury which can develop within a few hours or up to 21 days after the use of OsmoPrep or other OSP product. The injury is associated with deposits of calcium-phosphate crystals in the renal tubules that can permanently damage kidney function. OSPs may cause acute phosphate nephropathy because they result in dehydration, decreased intravascular volume, and hyperphosphatemia – all of which increase phosphate levels in the renal tubules.
FDA requires ‘Black Box’ Warning on OsmoPrep
In response to reports of acute phosphate nephropathy associated with sodium phosphate bowel preps, the FDA required the addition of a boxed warning to the prescribing information for OsmoPrep. According to the official FDA Press Release:
There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function, and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal antiinflammatory drugs [NSAIDs]).
Do I have an OsmoPrep 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 OsmoPrep lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by OsmoPrep, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.