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Judge Dan Polster of the United States District Court for the Northern District of Ohio recently issued a settlement order consolidating Fleet Phospho-soda laxative litigation. The order is Oral Sodium Phosphate Solution (OSPS) MDL 2066. The settlement will resolve most cases involving injuries caused by Fleet Phospho-soda.
Lawsuits began last month for four people who say the prescription bowel cleanser OsmoPrep caused them kidney damage that resulted in dialysis. OsmoPrep, made by Salix Pharmaceuticals, is a type of laxative called oral sodium phosphate, or OSP, used to cleanse the intestines prior to procedures such as colonoscopy. Salix Pharmaceuticals began marketing OsmoPrep in 2006. The drug generated more than $30 million in sales in 2008.
One year ago this month, the Food and Drug Administration (FDA) issued a black box warning on a common type of laxative known as oral sodium phosphate, or OSP, available both over-the-counter and by prescription. After years of investigation, the FDA finally alerted health care providers and the public of the risk of a serious kidney injury known as acute phosphate nephropathy associated with the use of OSPs.
Most people dread colonoscopies. Not only does the procedure, which involves a physician running a flexible tube through your colon and intestines, sound uncomfortable, the prep can be a real pain in the you-know-what. This is one reason why, when your doctor orders a colonoscopy, you’ll want to be sure you cleanse your bowel thoroughly and effectively to ensure that your doctor has a clear view of your colon. If not, you may have to repeat the procedure and the prep along with it.
The Food and Drug Administration (FDA) black box warning on oral sodium phosphates (OSPs) came late last year, but as early as 2003, doctors were beginning to make the link between OSP pills and solutions used to clear the bowel before colonoscopies and serious and permanent kidney injuries. As more and more reports of kidney damage and even complete kidney failure began to pour in to the FDA, the agency finally issued a mild warning in 2005. The black box warning on prescription OSP products would come three years later, after 21 more reports of serious kidney injuries. Soon after that FDA warning, C.B. Fleet quickly pulled its over-the-counter OSP products off the market.
Maker of bowel cleansing products and laxatives C.B. Fleet wants to sell its over-the-counter oral sodium phosphate (OSP) solutions to consumers even though the company recalled them six months ago after the Food and Drug Administration (FDA) issued black box warnings on prescription OSPs and raised serious concerns over the over-the-counter OSP products. The FDA had received numerous reports of a serious form of kidney injury known as acute phosphate nephropathy following the use of OSP.
Laxatives, like Fleet Phospho-Soda, an oral sodium phosphate (OSP) product, have been sold over the counter for more than a century, so it may come as some surprise that these products suddenly fall under a Food and Drug Administration (FDA) warning that links the use of OSPs to a serious kidney injury.
Some people who suffer from kidney problems may not realize their condition may be linked to products used to cleanse the bowel before medical procedures like colonoscopies, says Ben Locklar, shareholder with Beasley Allen Law Firm. It wasn’t until around 2005 that doctors began making the connection between oral sodium phosphate (OSP) products and a serious kidney injury known as acute phosphate nephropathy. Since then, more and more cases have been reported and hundreds of lawsuits have ensued.
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