DEAR DR. GOTT: I am writing with the hope that you will be able to give me some very important information on the matter of an FDA medical recall for fleet soda.
First, please let me say that I was advised that some time between March and April of 2010 this medication was removed by the FDA due to the fact that it was associated with giving people either liver or kidney disease. I had used this prior to having some gastric operations for about five years. My latest dose was taken about February 28, 2010 so I need to know whether or not it is still barred from usage.
One attorney advised me that legal litigation is ongoing about the drug but he didn’t tell me where and what court. Please provide any and all information concerning this matter.
DEAR READER: Fleet Phospho Soda (sodium biphosphate and sodium phosphate) is used for several purposes. It treats constipation, may relieve bowel impaction and cleanses the bowel prior to surgery, endoscopy, X-rays, and other intestinal procedures.
Before being given this medication, the prescribing physician should know if you have an eating disorder, kidney, heart or liver disease, an electrolyte imbalance, or dehydration because there could be serious life-threatening side effects on the kidneys. Before use, your physician should also have known if you have a history of bowel obstruction, perforation, colitis, inflammatory bowel disease, have or are recovering from an alcohol or drug addiction.
As I have stated many, many times, all drugs or remedies carry side effects. Those linked with this solution include diarrhea, nausea, cramping, and gas. Abdominal bloating can occur in almost 50% of all users; nausea in almost 40% of users; and abdominal pain in 1/3 of users. Renal impairment and acute failure and renal tubular necrosis during post-marketing experience has also been reported.
In December 2009 the Food and Drug Administration (FDA) issued a warning regarding the use of Fleet Phospho Soda and the prescription versions, Visicol and OsnoPrep were then required to display a black box warning on their labels, listing the associated risks. For what was considered a safe, over-the-counter laxative, Fleet Phospho Soda was ultimately found to cause seizures, rectal ulcers and bleeding, the inability to have a bowel movement after its use, loss of appetite, cardiac arrhythmias, and shortness of breath in some users. Some individuals with the kidney injury known as acute phosphate nephropathy required dialysis or transplant. Following the FDA warning, the manufacturer, C. B. Fleet Company voluntarily conducted a complete recall of their over-the-counter products and now the product is no longer available without prescription. It should be noted that the FDA is concerned regarding use of the product for bowel cleansing when higher than recommended doses are used. Currently there doesn’t appear to be a risk of acute kidney injury when the OTC products are used at normal dosing amounts. The bottom line – the FDA recommends consumers not use OTC oral sodium phosphate preparations for bowel cleansing.
So, to answer your question, some cases have been settled, others are pending. I cannot tell you what court they are being processed through but I am sure your attorney can do some investigation through the manufacturer, C. B. Fleet Company, a/k/a Global Laboratories in Lynchburg, VA 24502.
Readers who would like related information can order my Health Report “Kidney Disorders” by sending a self-addressed, stamped number 10 envelope and a $2 US check or money order directed to my attention at PO Box 433, Lakeville, CT 06039. Be sure to mention the title when writing or print out an order form from my website www.AskDrGottMD.com.
