Popular And Well Known Bowel Prep Has Dangerous Side Effects
In December of 2008, the Food and Drug Administration (FDA) released a warning regarding the use of Fleet Phospho Soda. Warnings on the popular over-the-counter drug, at that time, did not indicate the level of potential harm possible from Fleet Phospho side effects. In conjunction, the prescription versions of the drug, Visicol and OsmoPrep, were required to display “black box” warnings indicating the associated risks.
Most often, the product was used as an over-the-counter laxative, routinely given to individuals in preparation for colonoscopy procedures, and was considered both safe and effective. The drug is primarily made up of monobasic sodium phosphate, monohydrate, and dibasic sodium phosphate heptahydrate. Consumers using Phospho Soda bowel prep reported a wide range of serious side effects, including rectal bleeding, lack of bowel movement after use, seizures, sores and/or ulcers around the rectum, drowsiness, mood changes, loss of appetite, nausea, vomiting, uneven heart rate, limited or lacking urination, swelling, weight gain, and feeling short of breath.
However, these are not the most harmful side effects reported by consumers who used Fleet Soda. Acute phosphate nephropathy occurs in conjunction with use of OSP (oral sodium phosphate), and begins with the formation of crystals in the renal tubules. After prolonged use of Fleet Phospho, kidney damage occurred, in some cases so severe that transplants were required. Without dialysis or a transplant, instance of such severe Phospho Soda injuries most likely end in fatality. As with similar drugs in the OSP family like Osmo Prep, side effects are also severe and potentially life-threatening.
According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research: “Though rare, there are serious adverse events associated with the use of oral sodium phosphates—both prescription and over-the-counter products. In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products, or they did not drink sufficient fluids after ingesting OSP products.”
Acute phosphate nephropathy frequently occurs following the use of OSP products, and individuals with pre-existing conditions are most likely to exhibit the disease. Risk factors include people with eating disorders such as anorexia or bulimia, advanced age, hypertension, a history of heart disease, inflammatory bowel disease or colitis, a perforated bowel, a bowel obstruction, and other factors.
Following the FDA’s warning, C.B. Fleet Company conducted a complete Fleet Phospho-Soda recall of over-the-counter products. Since the FDA’s announcement, there has been more than one Fleet Phospho-Soda lawsuit settled, helping countless consumers receive compensation for their injuries. Because the Fleet Soda warnings on the initial OTC version of the drug did not indicate the severity of possible injury, it is no longer available without a prescription.
Since the recall, individuals have come forward to find an experienced Fleet Phospho Soda lawyer for their case. Over 150 Phospho Soda and Visicol lawsuit filings have been made since 2004. Most recently, in February of 2009, a product liability lawsuit was filed on behalf of three women who all experienced acute phosphate nephropathy days and weeks after use of the product. If you or anyone you know have suffered injury because of Fleet Phospho Soda, attorneys are available to help determine if you are eligible for compensation. Working with firms who have been involved with similar suits is essential to help you understand requirements involved in participating in a product liability lawsuit.
Fleet Phospho Soda Lawsuits Attorneys