It is estimated that thousands of Americans develop kidney disease from the laxatives they take prior to having colonoscopy and other examinations. Manufacturers often recommend twice the normal dosage of these drugs, known as oral sodium phosphates (OSPs), before an examination – and while that may help their bottom line, so many users have been injured that the FDA has issued a black box warning.

What are OSPs?

OSPs, or oral sodium phosphates, are laxatives commonly given to patients to cleanse the bowels prior to procedures such as colonoscopies, endoscopic and radiologic examinations and surgeries. The primary manufacturers and their products are:

• CB Fleet (OTC bowel preps, Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep – all are OTC drugs)
• Salix Pharmaceuticals (Visicol and OsmoPrep – both are prescription drugs)

These have been associated with severe and potentially fatal cases of renal or kidney failure.

OSPs link to kidney failure

In the 1990’s, manufacturers started recommending that patients double the dosage of OSPs given to patients before having colonoscopies. The result was that some patients experienced acute phosphate nephropathy, or kidney failure.

After receiving about 20 reports of kidney failure over the course of about two years, the U.S. Food & Drug Administration (FDA) issued an OSP safety alert in 2006. It then issued a black box warning on Salix’s drugs on Dec. 11, 2008. Fleet decided to recall any remaining products the same day and no longer sells these products in the U.S.

At the same time, the FDA asked Salix to develop a risk evaluation and mitigation strategy and to conduct post-marketing trials to assess the risk of this rare but very serious adverse event. The status of the latter is yet unknown.

Who’s at risk?

Older patients, those with decreased intravascular volume or preexisting kidney disease and those using certain medications such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and some nonsteroidal anti-inflammatory drugs (NSAIDs), are at the greatest risk.

Product liability lawsuits filed

As of 2007, more than 50 lawsuits in 20 states had been filed over Phospho-soda by a group of allied law firms. One of those cases involved a patient from Virginia who experienced kidney failure. He sued Fleet for $10 million in 2007 and recently settled with the company for an undisclosed amount. Lawsuits have been filed against Fleet in Canada, but the company has stopped selling these products there as well.

If you’ve been injured due to OSP, contact an experienced products liability attorney to discuss your situation and evaluate your options. Consultations with a lawyer are free, without obligation and are strictly confidential.