Fleet Phospho Soda Lawsuit
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Fleet Phospho Soda Lawsuit Information
In May of 2007 a lawsuit was filed against pharmaceutical firm C.B. Fleet Company over their product Fleets Phospho Soda. Fleet's over the counter product is a bowel cleanser that is widely used prior to colonoscopy procedures. The lawsuit alleges that Fleet Phospho Soda interacted with heart medication also being taken by the plaintiff and caused irreparable kidney damage. Since 2004 Fleet has faced over 150 lawsuits alleging kidney damage as the result of this product and has continued to sell it until very recently.
The lawsuit goes on to allege that damages suffered by the patient and plaintiff were avoidable because the company knew of the kidney risks associated with its product for at least ten years before the suit was filed. A chronology of events that took place over the past eight years suggests that there have been repeated reports from physicians about renal failures associated with the use of Fleet Phospho Soda and that Fleet continued to defend its product.
In December of 2005 the FDA issued its first public notice about the potential risk of using sodium phosphates for bowel cleansing because of the possibility of acute renal failure. Three years later on December 11, 2008 the FDA added the strongest safety warning available to oral phosphate drugs that are used before colonoscopies, citing reports of kidney damage in more than twenty complainants. The safety warning included a demand that all manufacturers of sodium phosphate bowel cleansers put a black box warning on their product packaging.
Four days later on December 15th of 2008 Fleet withdrew its product from the market. It is important to note that the FDA warning was issued to all makers of products similar to Phospho Soda, including Salix Pharmaceuticals who markets two sodium phosphate prep medications for colonoscopies called Visicol and OsmoPrep.
Fleet maintains that its product withdrawal as a response to the FDA warning is due to the fact that Phospho-soda is sold over the counter, while competitive products are only sold with a prescription. A physician who is aware of potential difficulties with sodium phosphate for a colonoscopy patient can suggest or prescribe some other form of laxative. An over the counter medication can be purchased and used by individuals who are ignorant of the drug's history and potentially harmful side effects.
The FDA warning focused on Fleet's Phospho Soda, stating that its use could result in kidney problems "in patients with no pre-existing health factors that would have put them at risk for developing kidney injury." Nevertheless, the overall warning is for sodium phosphate laxatives in general; the FDA has also had complaints about "acute phosphate nephropathy" with OsmoPrep and with Visicol. This condition impacts kidney function and can lead to renal failure.
Sodium phosphate laxatives are used by millions of people annually. There are bound to be further lawsuits over acute side effects caused by Fleet's Phospho-soda and many of the other similar products on the market.
The FDA also recommended that oral sodium phosphate prescription products be used with caution for bowel cleansing by the following at risk groups:
- People over 55 years of age,
- People who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and
- People taking certain medicines that affect kidney function, such as diuretics; or enzyme inhibitors that lower blood pressure; or receptor blockers designed to treat high blood pressure; or non-steroidal anti-inflammatory medications such as ibuprofen.
