We’ve all gone through the unpleasant task of preparing for a colonoscopy. Drinking an unpleasant liquid or popping pills for the purpose of giving the doctor a better view of our colon’s contents is…. anything but pleasant. Now, news has surfaced that, depending on the product you used to prepare for the procedure, the experience may not have been merely unpleasant– but downright dangerous.
On December 11, 2008, the FDA ordered the makers of Visicol and OsmoPrep to put a black box warning on their products alerting consumers to the fact that the drugs can cause kidney damage or death. The warning came after the FDA confirmed more than 20 reports of a severe kidney injury called acute phosphate nephropathy after people consumed the products. Acute phosphate nephropathy may progress resulting in: kidney failure, long-term dialysis, the need for a kidney transplant or death.
On the heels of the FDA warnings regarding Visicol and OsmoPrep, C.B. Fleet Company, the manufacturer of Fleet Phoso-Soda and Fleet Phoso Soda EZ Prep Bowel Cleansing System, stopped selling the products over-the-counter without a prescription.
Visicol, OsmoPrep, and the Fleet Phoso-Soda products all contain high doses of sodium phosphate that works to clean out peoples bowels before medical procedures such as colonoscopies.
According to Dr. Joyce Korvick, deputy director of the FDA’s Division of Gastroenterology Products at the Center for Drug Evaluation and Research, “Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The onset of the kidney injury in these cases varied, occurring n some within several hours of the use of the products and in other cases up to 21 days after use.”
The FDA’s warnings applicable to Visicol, OsmoPrep and Fleet Phoso-Soda products are particularly relevant to elderly people, because studies have repeatedly shown medical complications in the following demographics after they take oral sodium phosphate tablets:
- People over 55-years-old
- People suffering from dehydration
- People suffering from kidney disease
- People taking medications to control blood pressure (angiotensin converting enzyme inhibitors- to lower blood pressure or angiotensin receptor blockers- used to treat high blood pressure)
- People taking anti-inflammatory medications (including many arthritis medications or ibuprofen)
Symptoms of Acute Phosphate Nephropathy:
People with acute phosphate nephropathy may or may not have physical symptoms of their illness. In the case of those with no physical symptoms, blood tests that measure kidney function can be used to confirm the diagnosis.
The majority of people with acute phosphate nephropathy have some physical manifestation of the disease including one or more of the following symptoms:
- Reduced urine output
- Rapid energy loss
- Swelling in the legs and ankles
If you have a loved one who suffered acute phosphate nephropathy, kidney failure, the need for a kidney transplant, the need for long-term dialysis or died after taking a Fleet product, Visicol or OsmoPrep, you may have legal rights for damages against the manufacturer of the product. Additionally, if your family member was administered the drug at medical facility such as a nursing home or hospital, a cause of action may also exist against that facility.
At Rosenfeld Injury Lawyers, we pride ourselves on a hands-on approach when evaluating every case. We believe our rigorous case analysis with some of the leading medical professionals, helps secure the best results for our clients. As we have done for more than 30 years, we will evaluate your potential case at no expense for you. (888) 424-5757