OsmoPrep, Visicol Draw FDA Scrutiny to Drugmaker

The negative effect of sodium phosphate drugs on the kidneys of patients can no longer be ignored.

Enough evidence has accumulated for the Food and Drug Administration (FDA) to take action.

The FDA recently subjected Salix Pharmaceuticals, the maker of OsmoPrep and Visicol to a risk evaluation and mitigation strategy. The intention of the REMS is to manage the known serious risks associated with both of their oral-sodium phosphate products.

The move comes on the heels of revelations that the drugs can cause kidney damage and even acute nephropathy in patients in as little as 24 hours. Oral sodium phosphates are often used as bowel cleansers for patients preparing to undergo colonoscopies and other procedures.

Now the FDA wants to whether the benefits of OsmoPrep and Visicol outweight the potential risks. REMS generally help manage a known or potential serious risk associated with a drug or biological product. 

In the case of Salix, the REMS requires that the company provide:

  • A medication guide
  • A patient package insert
  • A communication plan
  • Elements to assure safe use
  • An implementation system
  • A timetable for assessment of the REMS

?Oral sodium phosphates have shown to be generally safe when taken in a single dose. But when two doses are administered, even as directed, the risk of serious kidney damage rises dramatically.

UPDATE: The FDA has required Salix to include the follwing boxed warning on all sodium phosphate drugs.

"WARNINGS There have been arare, but serious reports of acut 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, angiotension converting enzyme [ACE] inhibitors, angiotension receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]. See WARNINGS. It is importnat to use the dose and dosing regimen recommended (pm/am split dose). See DOSAGE and ADMINISTRATION."

If you have suffered an acute kidney injury following the use of a colonoscopy prep drug, it's critical that you contact an attorney to protect your legal rights for a possible recovery in a class-action lawsuit. 

If you've suffered injury or sickness due to sodium phosphate usage, contact the attorneys of Keller & Keller. Our firm includes experts in defective prescription cases.

James R. Keller
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Partner at Keller & Keller
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