FDA Requires Black Box Warning For Oral Sodium Phosphate (OSP) Products
December 11, 2008 – The U.S. Food and Drug Administration (FDA) mandated that oral sodium phosphate (OSP) products be given a boxed warning, commonly known as black box warnings, after receiving reports linking oral sodium phosphate products to acute phosphate nephropathy, an acute kidney injury. As a result, Salix Pharmaceuticals Ltd., has been required to add a Boxed Warning to the prescription drugs Visicol and OsmoPrep. The FDA also expressed concern about the use of related over-the-counter (OTC) laxatives (e.g., Fleet Phospho-soda). On December 11, C.B. Fleet voluntarily recalled its Fleet Phospho-soda products because the FDA concluded that OSP products should only be available by prescription.
The FDA has issued a nationwide warning of serious, life-threatening kidney injuries including acute phosphate nephropathy linked to prescription and over-the-counter laxatives including Visicol, OsmoPrep and Fleet Phospho-soda. Oral sodium phosphate (OSP) products are commonly used by patients preparing to undergo a colonoscopy (colon examination to detect precancerous growths) because OSP products cleanse the bowels.
- Oral Sodium Phosphates
- Acute Phosphate Nephropathy
- Fleet Phospho Soda Side Effects
- Fleet Phospho Soda Lawsuit
- Fleet Phospho Soda Lawyer
- Fleet Phospho Soda Recall
- Fleet Phospho Soda & Kidney Failure
- Visicol Black Box Warning & Kidney Injury Lawsuit
- Visicol Side Effects
- Visicol Lawsuit
- Visicol Lawyer
- Visicol & Kidney Failure
- Osmoprep Black Box Warning & Kidney Injury Lawsuit
- Do I Have an OSP Related Acute Phosphate Nephropathy Lawsuit?
Acute Phosphate Nephropathy
Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs. This is not the first action taken by the FDA regarding OSPs. Previously, on May 5, 2006, the FDA published the “Food and Drug Administration Science Background Paper: Acute Phosphate Nephropathy and Renal Failure Associated With the Use of Oral Sodium Phosphate Bowel Cleansing Products.”?nbsp; It took the FDA over two years, until December 11, 2008 to require the label to carry a Black Box Warning to this effect. On December 11, C.B. Fleet also voluntarily withdrew its over-the-counter OSP from the market because the FDA concluded that OSP products should only be available by prescription.
Do you have an Acute Phosphate Nephropathy or Oral Sodium Phosphate Lawsuit?
If you or a loved one has used oral sodium phosphate products and suffered from acute phosphate nephropathy, you may be entitled to legal compensation. Our oral sodium phosphate lawyers and attorneys are reviewing cases from all 50 states. Contact us today for a free and confidential case evaluation
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