According to new information reported to the U.S. Food & Drug Administration (FDA), oral sodium phosphate (OSP) drugs increase the risk of acute phosphate nephropathy in females and those with low body weight. These findings are important because the current labeling on OSP products does not indicate a difference in risk factors between men and women. Oral sodium phosphates are used to clean the colon prior to undergoing a colonoscopy procedure.
Free Oral Sodium Phosphate Case Evaluation: If you or a loved one has been injured by an oral sodium phosphate medication, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
A retrospective study conducted by researchers at NorthShore University Health System in Evanston, Illinois has analyzed the renal risks of oral sodium phosphate tablets. The study, which was titled Renal risks of sodium phosphate tablets for colonoscopy preparation: A review of adverse drug reactions (ADRs) reported to the Food and Drug Administration (FDA), found that renal adverse drug reactions from sodium phosphate tablets are more common in females, with a mean body weight lower than the national average weight. Popular OSP products include OsmoPrep, Visicol and Fleet Phospho-soda, which was been pulled from the U.S. market in December 2008.
Researchers extracted more than two million files from the FDA’s Adverse Event Reporting System (AERS) from 2004 to 2009, and found that 178 cases from tablet preparations (71 % females) were identified with increasing numbers of renal adverse drug reactions each year. “Using computer simulation, and subsequent single-dose pharmacokinetic analysis with Fleet’s Phospho-soda, our group demonstrated that individuals (especial females) of lower body weight developed marked elevation in serum phosphate levels following ingestion of the preparation.”
Taking these figures into consideration, the group that conducted the study recommends avoidance of OSPs in women, particularly those of smaller weight and stature. Additional studies are needed to confirm this association and establish causality.
OSPs and Acute Phosphate Nephropathy
Acute phosphate nephropathy is characterized by damage to the kidneys caused by the formation of phosphate crystals within the renal tubes. The condition is commonly associated with the ingestion of oral sodium phosphate bowel purgatives prior to colonoscopy procedures. In addition to sex (female) and low body weight, the risk for acute phosphate nephropathy is increased with age, dehydration, or in the presence of hypertension or if the patient is taking an ACE inhibitor or angiotensin receptor blocker. Signs and symptoms may include (but are not limited to):
- abnormal heartbeat
- difficult urination
- general discomfort and fatigue
- high blood pressure
- lower back pain
- muscle twitches and cramping
According to the U.S. Food & Drug Administration (FDA), “Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued.”
OSP Side Effects
In addition to the increased risk of acute phosphate nephropathy, OSPs like Visicol and OsmoPrep have been linked to the following side effects:
- abdominal bloating & pain
- severe kidney damage
- renal failure
- facial swelling
- throat tightness
Injured by oral sodium phosphates? Contact us today.
If you’ve suffered from any of the side effects listed above after taking OsmoPrep or Visicol, it is important that you meet with a lawyer who specializes in OSP side effects lawsuits. During your free initial consultation, our team of experienced attorneys will thoroughly evaluate your claim and give you expert advice on how to pursue your case. Our defective drug lawyers work on a contingency basis, meaning that no payment for services is due unless your case is won.
Do you have an Oral Sodium Phosphate Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in oral sodium phosphate (OSP) lawsuits. We are handling individual litigation nationwide and currently accepting new acute phosphate nephropathy cases in all 50 states.