In December 2008, the U.S. Food & Drug Administration (FDA) issued reports of renal (kidney) failure caused by OSP products. Oral Sodium Phosphate (OSP) products have been shown to cause acute phosphate nephropathy, which is a type of acute kidney injury. This injury can lead to renal failure and permanent kidney impairment.
OSP products are used to cleanse the bowels and intestines before a colonoscopy or other medical procedures. However, they can lead to adverse effects resulting in the development of acute kidney injury. According to the FDA, it is believed deposits of calcium-phosphate crystals in renal (kidney) tubules cause acute phosphate nephropathy.
Patients over the age of 55, those who already suffer from bowel obstruction, active colitis and baseline kidney disease and patients who take medication, which affects how their kidneys function, have an increased risk of harm.
Patients may not experience any of these symptoms during the early stages of acute nephropathy. Blood tests, which measure kidney function, may alert patients to potential problems. Kidney injury can occur only a few hours after taking OSP products or it can take up to 21 days for injury to occur.
The FDA report focuses on both prescription and over the counter OSP products. Both have been shown to cause problems. The FDA warned against consumers using over the counter OSP products, such as, Fleet Bowel Prep and Fleet Phospho-Soda. C. B. Fleet Company manufactures both of these products. A few day after the FDA warning, C.B. Fleet voluntarily recalled both of its over the counter OSP products
The recall was directed at wholesalers and retailers. Prescription OSP products, such as, Visicol and OsmoPrep, have to add a Black Box warning to their labels. A Black Box warning is highest warning the FDA gives. The FDA is also requiring their manufacturer, Inkine Pharmaceutical Company, to evaluate that the benefits of the OSP products outweigh the risk of acute phosphate nephropathy. In addition, they must conduct a postmarketing clinical trial to assess the risk of kidney injury caused by the use of OSP products.
If you believe that you or a loved one has suffered as a result of taking Fleet Bowel Prep or Fleet Phospho-Soda, you may want to speak with a personal injury attorney regarding a potential claim.
Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.