FLEET PHOSPHO-SODA RECALLED FROM MARKET
Fleet Phospho-soda is an over-the-counter laxative product used regularly as a bowel cleanser and preparatory solution for colonoscopy and other intestinal procedures and surgeries. Use of Fleet Phoshpa-soda at the prescribed dosages required for colonoscopy can cause severe kidney damage. Litigation against the makers of Fleet Phospho-soda is being prepared now.
C.B. Fleet Co., Inc., makers of Fleet Phospho-soda, Fleet Phospho-soda Accu-Prep, and Fleet Phoshpo-soda EZ-prep have known about the risk of kidney and renal-system side effects related to these products for several years, yet have failed to warn patients about the problems. This over-the-counter laxative has been associated with the development of severe kidney damage or renal failure known as Acute Phosphate Nephropathy.
Acute Phosphate Nephropathy, also known as Acute Nephrocalcinosis, is a rare but very serious form of kidney injury that can occur after the use of sodium oral phosphate products, like Fleet Phospho-soda, OsmoPrep, and Visicol. These laxative products are prescribed at high doses to clear out the bowels before medical procedures like colonoscopies.
Acute Phosphate Nephropathy can develop within hours of taking the drug, or up to 21 days after use. In many cases this damage is permanent and can require dialysis treatment, a kidney transplant, and even result in death. Symptoms of kidney problems related to Fleet Phospho-soda may include:
· Elevated Blood Pressure
· Irregular Heartbeat
· Fluid Retention
· Muscle Spams/Twitching
· Seizure
The attorneys at Lanham Blackwell are accepting cases for review from patients with Acute Phosphate Nephropathy, also known as Acute Nephrocalcinosis, or those who may have experienced any of the symptoms of Fleet Phospho-soda kidney damage.
In December 2008, the FDA released a warning stating that two prescription sodium phosphate drugs, OsmoPrep and Visicol, would require a “black box” warning about the side effects and dangers of acute phosphate nephropathy. The “black box” warning is the strongest warning that can be placed on a prescription drug.
Fleet had been heavily marketing their over-the-counter oral sodium phosphate laxative, Fleet Phospho-soda, as a bowel prep when taken at higher doses.
Timeline
1996: FDA warns C.B. Fleet, makers of Fleet Phospho-soda, that the company had failed to demonstrate the safety of the product as a bowel cleanser.
1997: Fleet began to receive reports of death in Australia related to the use of Fleet Phospho-soda as a bowel prep solution before surgery and medical procedures.
1998: Again, the FDA issued formal warnings to C.B. Fleet Co., Inc. that they had failed to demonstrate the safety of using their product in doses high enough to be used for bowel preparation.
2001: The FDA issues a “Science Backgrounder” alerting consumers about the potential safety and health issues with the sodium phosphate drug Fleet Phospha-soda
2002: J&J/Merck Canada issued an open letter to Canadian healthcare providers warning about the risks of using Fleet Phospho-soda in the high doses recommended by Fleet for bowel prep. In defense, C.B.Fleet, Co., Inc. issued it’s own open letter to doctors touting the safety of their product for bowel cleansing before medical procedures.
2003: A renal pathologist at Columbia Presbyterian Hospital, Dr. Glen S. Markowitz, positively identified cases of kidney failure directly related with the use of Phospho-Soda as a bowel cleanser.
2005: Dr. Markowitz published results of an extended study examining oral sodium phosphate solutions as an under-recognized cause of renal failure and kidney damage.
2006: The FDA issued a formal “Alert” regarding the role of sodium phosphate solutions in occurrences of acute phosphate nephropathy.
2007: First medical journal article was published stating that the incident rate of kidney/renal failure due to use of oral sodium phosphate is approximately 1 in 100.
December 11, 2008: The FDA issued the formal “Alert” stating that the use of Fleet Phospho-soda can lead to kidney failure in “patients with no pre-existing health factors that would have put them at risk for developing kidney injury.”
December 15, 2008: After 5 years of continued promotion of Phospho-Soda as a “safe bowel preparation”, Fleet finally recalls Phospho-Soda from the market, stating that it may be reintroduced as a prescription product at a later date, if approved by the FDA.
The attorneys at Lanham Blackwell are evaluating potential claims for individuals who have suffered from any of the side effects related to acute phosphate nephropathy, also known as Acute Nephrocalcinosis, caused by oral sodium phosphate products like Fleet Phospho-soda. If you feel that you or your family are entitled to monetary compensation from a Fleet Phospho-soda lawsuit, please contact Lanham Blackwell today.