Fleet Phospho Soda
If you have suffered a personl injury as a result of the dangerous drug Fleet Phospho Soda, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation and dangerous drug litigation against pharmaceutical companies.
Fleet Phospho Soda Products Safety Measures from FDA
FDA is announcing new safety measures for oral sodium phosphate (OSP) products used for bowel cleansing before colonoscopies and other procedures. These products are associated with acute phosphate nephropathy, a rare but serious type of kidney injury. The events have been reported with the prescription products Visicol and OsmoPrep, and also over-the-counter sodium phosphate products when they are used as bowel cleansers.
FDA first warned about this problem in 2006, but cases of kidney injury continue to be reported. So FDA is requiring the manufacturer of Visicol and OsmoPrep to take several steps. First, a boxed warning about the risk of acute phosphate nephropathy will be added to the product label. The manufacturer will also conduct a new clinical trial to further study the risk of acute kidney injury with these products, provide a Medication Guide for patients, and implement a risk evaluation and mitigation strategy to ensure that the benefits of using these products outweigh their risks.
FDA believes that oral sodium phosphate products should be available only by prescription when they are used for bowel cleansing. Because of this, C.B. Fleet Company has voluntarily recalled the company's oral sodium phosphate products sold over the counter, (Fleet Phospho-soda and Fleet EZ-PREP) and has advised healthcare professionals not to instruct patients to use these products for bowel cleansing. Unico Holdings, Inc. is also recalling its OTC oral sodium phosphate products sold for bowel cleansing.
Health professionals should use caution when prescribing Visicol or OsmoPrep for patients who may be at higher risk of kidney injury. This includes those over aged 55, or those who have kidney disease, bowel obstruction, active colitis, or are dehydrated. It also includes patients taking drugs that affect renal perfusion or function such as diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs) and possibly NSAIDS.
Prescribers should instruct patients about how to prepare for their procedures, and tell them to avoid dehydration by drinking enough clear liquids before, during and after bowel preparation. They should also tell patients to be alert for symptoms of acute kidney injury, including malaise, lethargy, drowsiness, decreased urine volume and swelling of the ankles, feet and legs.
C.B. Fleet Company Fleet Phospho Soda Voluntary Recall Notice
Following the issuance of FDA's Safety Alert on Thursday stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only, C.B. Fleet Company immediately announced a voluntary recall of their over-the-counter products Fleet® Phospho-soda® and Fleet® Phospho-soda® EZ-Prep® Bowel Cleansing System. The voluntary recall is directed to retailers and wholesalers.
The recall decision was made to address FDA's determination that oral sodium phosphate solutions used for bowel preparation prior to medical procedures such as colonoscopy should only be available by prescription, and consumers should not be using over-the-counter products for bowel cleansing. Since Fleet's Phospho-soda products are currently labeled and sold as over-the-counter products, Fleet decided voluntarily to remove them from the market as expeditiously as possible to address the FDA's decision that the products be available by prescription only.
As FDA has recommended that doctors not direct their patients to use these over-the-countervproducts for bowel cleansing, C.B. Fleet requests that consumers not purchase these products forvbowel cleansing and contact their physician for alternatives if their physician has recommendedvtheir use for this purpose.
