The Warnings Include Other Oral Phosphate Drugs Like Osmo Prep And Visicol
In 2008, the U.S. Food and Drug Administration issued Fleet Soda warnings to the general public regarding the safety of the popular laxative product. After almost ten years of back and forth between the government agency and the parent company, enough of a risk was determined to warrant a widespread recall of all the products in the line. The Fleet soda warnings pertain to the oral sodium phosphate (OSP) available both as an over-the-counter drug and prescription, mostly due to the incidence of kidney failure and other injuries among consumers.
Since the mid-90s, there was growing concern in the medical community regarding the safety of the commonly prescribed bowel cleanser. Millions of Americans were instructed to take the product, often unaware of the potential hazards. In an official statement by the FDA, the agency warned that “healthcare professionals should be aware that acute phosphate nephropathy, a type of acute renal failure, is a rare, but serious adverse event associated with the use of oral sodium phosphate products for bowel cleansing. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution and one patient who used OSP tablets. The bowel cleansing doses of OSP solutions and Visicol provide nearly identical amounts of sodium phosphate: about 60 grams of sodium phosphate per dose. No cases of acute phosphate nephropathy have been associated with OsmoPrep, an OSP tablet bowel preparation, approved in March 2006.”
Nephropathy is a term that indicates kidney injury, and can be brought on by a number of factors including disease, over use of analgesics, long-term exposure to lead, types of diabetes and lupus, and high blood pressure. The incidence cited in the warnings, however, was known to occur in individuals who had no pre-existing diseases known to contribute to renal failure. Acute phosphate nephropathy has been known to occur in healthy individuals who used the drug, either as a prescription or over-the-counter, in preparation for a colonoscopy. The disease itself is caused by a buildup of crystals in the renal tubules, which leads to renal failure. In many cases, dialysis or entire kidney transplants have been required.
While there have always been warning labels on the product, they allegedly failed to represent the true risk and possible harm associated with taking the drug. Other side effects include 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 shortness of breath.
In December 2008, the FDA began requiring a “black box” on these labels; this is the most serious alert that the agency can mandate. It means that medical studies have indicated that the drug carries the risk of severe or even life-threatening adverse effects.
Since the consumer alert, many individuals have come forward seeking legal compensation for injuries they believe are related to the drug. If you, or someone you love, is thinking of pursuing a Fleet Phospho-Soda lawsuit , the most important first step is receiving proper medical attention. Working with the right doctor to assess any damage and instance of kidney failure is essential. Once the health issues have been attended to, you should then seek legal representation. Working with seasoned lawyers will help you get the information you need on the recall, and they will determine if you are eligible for compensation for your injuries.
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