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Fleet® Phospho-Soda® Solution is a laxative that works by pulling water from the body into the bowel, which then helps to soften the stool and result in a bowel movement. Fleet Phospho Soda and the FDA The Food & Drug Administration (FDA) stated on December 11, 2008, that a Boxed Warning would be adding to the prescription Oral Sodium Phosphate (OSP) products Visicol® and OsmoPrep®, to advise people of the potential risk of acute phosphate nephropathy, an acute kidney injury. Patients routinely take Oral Sodium Phosphate products to cleanse the bowel before a colonoscopy and other medical procedures. The FDA stated it was equally concerned about over-the-counter OSP products, including Fleet® Phospho-soda®, when used at higher doses for bowel cleansing. The available data did not demonstrate a risk of acute kidney injury when Fleet® Phospho-soda® was used at the lower doses for laxative use. However, the FDA added that: …”when used for bowel cleansing, these products have the same risks as prescription Oral Sodium Phosphate products. The FDA plans to amend the labeling conditions for over-the-counter OSP products to address this concern with bowel cleansing use. In light of continued receipt of reports of acute phosphate nephropathy, FDA is recommending that consumers not use over-the-counter OSPs for bowel cleansing.” Oral Sodium Phosphate products should not be used by children under 18 years of age, or in combination with other laxative products that may contain sodium phosphate. Use with Caution
The FDA recommends that OSP prescription products be used with caution for bowel cleansing by the following at-risk groups:
• Over 55 years of age• Those with dehydration, kidney disease, acute colitis, or delayed bowel emptying issues
Caution must also be exercised by people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly non-steroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications). On the same day that the FDA released its statement, C.B. Fleet Company – the makers of Fleet® Phospho-Soda® - immediately announced a voluntary recall of the product. If you were injured by Fleet® Phospho-soda®, or if you have a loved one who was injured by Fleet® Phospho-soda®, please contact us immediately for a potential case evaluation. The initial consultation is free of charge, and if we agree to accept your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. You may be entitled to compensation for your injuries; we take all cases on a contingency fee basis, which means you do not pay for our services unless you receive an award/compensation.
In all personal injury cases, it is extremely important that measures be taken promptly to preserve evidence, to investigate the case in question, and to enable physicians, attorneys, or other expert witnesses to thoroughly evaluate any injuries. For a free evaluation of your potential claim, call 1-888-446-8087, or fill out an intake form on this website by clicking on "Can We Help You?" on the upper right hand corner of the home page. You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires. We will respect the confidentiality of your information to the fullest extent. Form submissions are relayed to us through our highly secure servers.
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