Patients scheduling colonoscopies are very concerned about ingesting oral sodium phosphates (OSPs) beforehand – and rightfully so after the FDA recently issued a black box warning on one company’s prescription OSPs and another pulled its over the counter OSPs. Here’s an overview of OSP manufacturers and their products; a brief history of OSPs; FDA safety alerts, black box warnings and recalls and information on the product liability lawsuits that have been filed.

OSP manufacturers & their products

CB Fleet, Inc., located in Lynchburg Virginia, manufactured the over the counter bowel preparation (OSP) drugs, Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep – all of which are now off the market. Salix Pharmaceuticals, located in Morrisville North Carolina, manufacturs the prescription drugs Visicol and OsmoPrep – which are still on the market. All of these drugs are, or were, used to cleanse the bowels before patients underwent colonscopies.

A brief history of OSPs

In the 1990’s, the manufacturers (Fleet, at least) started recommending double the dosage of these products be given to patients prior to colonoscopies. The result was that some patients experienced acute phosphate nephropathy (APN), or kidney failure. It is still being determined whether or not OSP manufacturers knew about the increased risk of APN when they made those recommendations. However, legal experts say that even if they did not know, they should have known.

Safety alerts, black box warnings & recalls

OSPs have been the subject of FDA safety alerts, FDA black box warnings and recalls. Here’s a quick overview:

• Safety alert. The U.S. Food & Drug Administration (FDA) issued a safety alert on OSPs in 2006 after receiving approximately 20 reports of kidney failure in the previous two years from patients who had taken the drugs. To view that alert, please click here.
• Black box warning. The FDA issued a black box warning on Salix’s drugs on Dec. 11, 2008. A black box warning is the harshest warning the FDA can give and it means that using the product could cause serious injury or death. The FDA also 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. To view that warning, please click here.
• Recall. After the FDA’s black box warning on Salix’s products, Fleet recalled their OSP products the very same day and no longer sells the products in the U.S. Salix has not yet recalled its products. To view the recall letter, please click here.

Product liability lawsuits filed

As of early 2009, approximately 70 lawsuits have been filed against Fleet in numerous states – and some have already been resolved. One of those cases involved a patient from Virginia who experienced kidney failure and sued Fleet for $10 million in 2007. He ended up settling with the company for an undisclosed amount.

Lawsuits have also been filed against Fleet in Canada, but the company has stopped selling these products there as well. Most recently, Fleet has sought to consolidate the lawsuits filed against it in an MDL (multi-district litigation) to avoid duplicating efforts. The hearing on that matter will happen in late May 2009. If you’ve taken OSPs and would like to speak with an experienced product liability attorney, please click here.