Pharmaceutical company claims controversial laxatives are safe
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Six months ago, the pharmaceutical company C.B. Fleet pulled two laxative drugs from store shelves. Now, according to the
Lynchburg (VA) News and Advance, the company is seeking to reintroduce thousands of cases of the recalled drugs onto the market.
C.B. Fleet, which is based in Lynchburg, is currently facing 38 federal lawsuits concerning the laxatives. The suits were recently consolidated into one federal district court (the Northern District of Ohio) in order to share pre-trial proceedings and discovery. The lawsuits allege that the recalled drugs caused serious kidney damage. Other lawsuits remain in state courts where jurisdiction rules allow.
The drugs are Fleet Phospho-soda and Fleet Phospho-soda E-Z Prep Bowel Cleansing System. Both were over the counter products classified as oral sodium phosphates. C.B. Fleet officials maintain that, when used as directed, the recalled drugs are safe. There have been discussions about making these drugs available by prescription.
The drugs Visicol and OsmoPrep are available by prescription only and the FDA is requesting a Box Warning be added to the label. The Food and Drug Administration issued a warning in December 2008, concerning oral sodium phosphates. The FDA linked them to acute phosphate nephropathy (an acute kidney injury involving a buildup of calcium phosphate crystals). The agency specifically warned that oral sodium phosphates should not be used for bowel cleansing without a prescription due to these serious risks.
The FDA also reported that acute phosphate nephropathy had developed in patients after use of an oral sodium phosphate even when the patients had no identifiable factors putting them at risk for such a kidney injury.