Fleet Phospho Kidney Damage Can Result from Bowel Prep Before Surgery

FDA Recall On Oral Phosphate Solutions That Form Crystals That Block Renal Tubules

As indicated in the Food and Drug Administration’s December 2008 consumer alert, Fleet Phospho kidney damage occurred in a small number of individuals using the laxative when it was administered prior to colonoscopies. After the FDA released its warning, the parent company recalled its over-the-counter products and affixed a “black box” warning to prescription strength versions. Up until that point, though there were a few instances of previous litigation and at least one related death, most consumers and doctors believed the product was both safe and effective. However, because larger doses of the over-the-counter version were as potent as the prescription version, serious consequences arose.

The negative side effects can develop into acute phosphate nephropathy if undiagnosed, which poses a series of risks including kidney injury and failure, as well as death. The disease is caused by a buildup in the renal tubules made up of crystalline structures, and those with severe cases often require dialysis to combat the symptoms. Untreated, the disease can be fatal.

While many of the confirmed cases of renal failure and nephropathy occurred among patients without pre-existing conditions, there are other factors that pose higher risks of developing the disease. These people include those with eating disorders, such as anorexia or bulimia, patients with heart conditions, high blood pressure, diabetes, irritable bowel syndrome, Crohns disease, or any bowel problems. To complicate matters further, greater risks are also associated with the use of many common medications such as narcotics, diuretics, NSAIDs, antibiotics, antidepressants, anti-nausea medications, anti-psychotics, blood pressure medications, and some common migraine drugs; these can increase the risk of patients developing serious complications.

Indications of related health problems include a variety of symptoms, such as swelling of the hands and feet, decreased urine, malaise, high blood pressure, muscle spasms, back pain, and seizures. Additionally, symptoms of renal injury include rectal bleeding, lack of bowel movement after use, seizures, sores and/or ulcers around the rectum, drowsiness, mood changes, loss of appetite, nausea, vomiting, uneven heart rate, limited or lacking urination, swelling, weight gain, and shortness of breath.

The FDA has issued warnings that note the problematic reports that have spawned lawsuits. Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, said in an official statement: “Though rare, there are serious adverse events associated with the use of oral sodium phosphates—both prescription and over-the-counter products. In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk.”

There have already been related product liability lawsuits. In February of 2009, three women came forward as part of a suit regarding OSP products. All three had purchased the over-the-counter drug and took high doses as preparation for upcoming colonoscopies. They allege that the company did not alert consumers to the risks associated with use or test the product thoroughly before releasing it to the general public.

If you are considering using this product, you should consider the associated hazards carefully. It is best that you and your doctor speak at length about the possible side effects and consider the benefits in light of those risks. There are many other options for laxative and bowel prep that are considered less of a concern.

However, if you are currently using the drug in one of its prescription forms - for example, Visicol or OsmoPrep - and have exhibited some of these symptoms, you should contact your doctor immediately. While it can take up to a month for some individuals to present associated effects related to Phospho Soda injuries , you must seek medical help as soon as you suspect a problem. The greatest contributor to the survival rate with the disease is early detection. Once you have sought the help of your physician, you may want to consider legal action as well. Consulting with your doctor and lawyer will determine if you are eligible to participate in current cases regarding product liability or are owed compensation for your injury.