Oral Sodium Phosphates Linked to Kidney Damage

St. Louis, MOIf you took an oral sodium phosphate (OSP) to clean your bowels prior to a colonoscopy and have developed kidney damage, there is a chance your health problems are linked to the use of the OSP. In 2008, certain oral sodium phosphates, including OsmoPrep and Visicol were given a black box warning, the highest warning required by the FDA, alerting patients to the risk of kidney damage.

"The OsmoPrep and the Visicol are prescription drugs," says Jeff Lowe, attorney at The Lowe Law Firm. "There is also an over-the-counter preparation called a Fleet enema. These also have been linked with acute kidney damage when used as bowel preparation for a colonoscopy but not when used as a laxative. In 2008, they were also given a black box warning that warns of the potential risks of renal failure."

According to Lowe, there are some people who are more susceptible to renal failure than others. Some factors that can affect a patient's susceptibility include having pre-existing kidney damage, being dehydrated while taking the OSP, being on an angiotensin-converting enzyme (ACE) inhibitor while taking the OSP, being on an angiotensin receptor blocker (ARB) while taking the OSP, having increased bowel transit times (such as a bowel obstruction or colitis), or being on a non-steroidal anti-inflammatory drug (NSAID) while taking the OSP. A final risk factor is being 55 years of age or older at the time the OSP is taken.

"A definitive diagnosis can be made by a biopsy of the kidney, which will show excess phosphate in the kidney," Lowe says. "What they have found is that patients develop phosphate nephropathy. It is important that people be aware that kidney damage can happen and that certain people are susceptible to developing kidney damage. Sometimes, the kidney damage is transient, meaning the patient heals. Other times the patient suffers from chronic kidney problems. The best thing to do is go to a doctor and be tested."

Lowe says that there was a petition to withdraw certain oral sodium phosphates from the market, however the FDA determined that an increased warning was sufficient.

Patients who have taken OsmoPrep, Visicol or high doses of Fleet Phospho-soda and are experiencing symptoms of kidney damage should see a doctor immediately to be tested for kidney failure. From there, they can contact an attorney to determine their legal options.

"There is a potential statute of limitations issue, depending on the state in which the patient resides," Lowe says. "The black box warning was announced on December 11, 2008, so if the statute of limitations runs from that date, people should be fine. There are, however, earlier studies put out [linking oral sodium phosphates to kidney damage]. For example, there was an FDA alert in March 2006. Also, in 2006, there was a joint task force of the American Society of Colon and Rectal Surgeons, the American Society for Gastrointestinal Endoscopy and the Society of American Gastrointestinal and Endoscopic Surgeons that issued a consensus statement. They looked at scientific literature and recommended dosing instructions and warned people to be cautious.

"For products still on the market, the statute of limitations typically runs from the black box warning because the FDA has determined that the previous warnings were inadequate. People should act quickly because the sooner a lawsuit can be filed, you can make sure the statute of limitations is protected," Lowe says.

"The liability theory in these cases is product liability, failure to warn. There is a duty to warn of dangerous conditions—for example, if a product needed certain warnings to make it safe. Plaintiffs can sue the manufacturer for what they knew or should have known, and did not warn consumers about. There was information accumulating throughout the years about this risk of kidney failure, but they chose not to warn consumers."