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Colonoscopy Drugs to Get Most Severe Warning

-December 12, 2008

OsmoPrep and Visicol, two prescription medications used prior to colonoscopy procedures in order to clean out the bowels, will have their warning labels revised to include the strictest safety warnings possible, as required by the U.S. Food and Drug Administration (FDA). FDA officials released a statement regarding the new Boxed Warning for these products Dec. 11.

Oral Sodium Phosphate Drugs

The two drugs — made by Salix Pharmaceuticals — are oral sodium phosphate (OSP) medications. The FDA's statement recommends that over-the-counter (OTC) oral sodium phosphate drugs should not be used for bowel cleansing at all, in part because of the reports to the FDA of an OSP-caused kidney injury known as "acute phosphate nephropathy."

Acute Kidney Damage Risk

The FDA is requiring Salix to do the following:

  • Distribute a new medication warning that describes the risks of OsmoPrep and Visicol.
  • Conduct a postmarketing clinical follow-up study to assess the risk of acute kidney injury that may accompany these drugs, especially to investigate which patients are most vulnerable to kidney damage.
  • Develop and use a risk-evaluation and mitigation strategy (REMS) to make sure that the benefits of their products outweigh the risk of acute phosphate nephropathy.

Over-the Counter Versions Are Risky Too

The FDA noted that many OTC phosphate drugs — such as Fleet Phospho-soda — are marketed only to treat constipation, but consumers often use them at higher doses to clean the colon. The recent FDA statement noted that "When used for bowel cleansing, these products have the same risks as prescription" drugs.

Dr. Joyce Korvick, director of the FDA’s section overseeing digestive products, said that symptoms of kidney damage may not appear until long after the kidney damage itself has occurred.

Compensation for Injuries

Individuals who suffer injuries after taking a defective drug may be eligible to recover compensation for losses including:

  • Medical costs
  • Physical pain
  • Emotional pain and suffering
  • Lost wages due to the loss of ability to work

(Source: MSNBC)

If you have been harmed by a drug such as Visicol or OsmoPrep, contact us to speak with a defective drug attorney who will evaluate your situation and help you recover compensation for your losses.

 

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