The FDA's Actions Regarding Fleet Phospho-Soda

The FDA has been concerned about the use of sodium phosphates for bowel cleansing purposes since at least 2001. However, while the FDA knew of the potential dangers of sodium phosphates, it took few appropriate actions to protect patients from the risks associated with sodium phosphate medications such as Fleet Phospho-soda. Over the years, the FDA has continued to collect adverse reports associated with the use of sodium phosphates in preparation for colonoscopies and other medical procedures and has issued the following guidance to patients and physicians.

September 2001: Science Backgrounder on Sodium Phosphates

In September 2001, the FDA issued a “Science Backgrounder: Safety of Sodium phosphates Oral Solutions” which was written to provide safety information regarding sodium phosphates, such as Fleet Phospho-soda, to patients and health care providers. According to the FDA’s safety information, patients taking more than 45 ml of oral sodium phosphate solution were at risk for dangerous electrolyte disturbances that could result in serious side effects including renal failure and death. In 2001, the FDA concluded that physicians should be aware of Fleet Phospho-soda side effects for people with certain conditions or who were on certain medications that might increase the risk of developing side effects. The FDA also suggested that physicians obtain certain baseline and post-treatment levels to determine if the patient is in danger.

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March 2006 FDA Alert

In March 2006, the FDA issued an alert “Healthcare Professional Sheet - Oral Sodium Phosphate (OSP) Products for Bowel Cleansing” to let patients and physicians know that acute phosphate nephropathy was a potential side effect or oral sodium phosphates. Fleet Phospho-soda was specifically named in the alert. At that time there were 21 documented cases of acute phosphate nephropathy associated with oral sodium phosphates and one documented case associated with sodium phosphate tablets.

December 2008 FDA Alert

The December 2008 FDA Alert “Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)” alerted patients and physicians to the dangers of using oral sodium phosphate products even if the patient did not have identifiable risk factors. As in 2006, the primary concern of the FDA was the risk of acute phosphate nephropathy. Accordingly, the FDA required that over the counter sodium phosphate solutions no longer be used for bowel cleansing purposes. The products, such as Fleet Phospho-soda were allowed to remain on the market to treat constipation.

Also, in December 2008 the FDA responded to a 2003 request by C.B. Fleet, the manufacturer of Fleet Phospho-soda. C.B. Fleet had requested that the FDA to modify the professional labeling of Fleet Phospho-soda to allow its use for bowel cleansing. The FDA denied C.B. Fleet’s request approximately 5 ½ years after it was made.

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While the FDA has been aware of the potentially dangerous Fleet Phospho-soda side effects for many years, it has failed to take the steps necessary to protect patients from the dangers of Fleet Phospho-soda acute phosphate nephropathy and liver damage. If you have been hurt, or a loved one has been killed, by the use of Fleet Phospho-soda, then you are encouraged to speak with a Fleet Phospho-soda attorney to discuss your legal rights as soon as possible.

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