Oral Sodium Phosphate (OSP) products used for bowel cleansing prior to colonoscopies have been linked to an increased risk of acute phosphate nephropathy.
FDA Warning on Oral Sodium Phosphate Products
In December 2008, the FDA announced that it was requiring a so-called ‘black box’ warning on OSP products regarding the risk of patients developing acute phosphate neuropathy. OSP products include Visicol, OsmoPrep, & Fleet Phospho-soda. These products are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.
Acute Phosphate Neuropathy
Acute phosphate nephropathy is an extremely serious kidney injury. The FDA black box warning about this condition came after more than 20 reports that were linked to the use of oral sodium phosphates. The FDA reports that of the 20 cases of acute phosphate nephropathy associated with the oral sodium phosphates, five cases were reportedly life-threatening and 10 resulted in hospitalization.
Users: Take Extreme Caution
Health professionals should use extreme caution when prescribing OSP products. This includes patients over 55, as well as those who have kidney disease, bowel obstruction, active colitis, or are dehydrated. It also includes patients taking drugs that affect renal perfusion or function such as diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs) and possibly NSAIDS.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Oral Sodium Phosphate-induced kidney injury and acute phosphate neuropathy cases in all 50 states. If you or somebody you know has been injured by oral sodium phosphates, you should contact our firm immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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