Bowel Cleansers Declared Safe By C.B. Fleet Following Recall

Thousands of doses of recalled drugs might soon be back on store shelves, just months after being recalled.

On June 29, 2009, a high-ranking official with drugmaker C.B. Fleet declared that the two laxative products are safe when taken as directed.

Chief Scientific Officer Chris McDaniel was talking specifically about Fleet Phospho-soda EZ-Prep Bowel Cleansing System and Fleet Phospho-soda. Both drugs are oral-sodium phosphate-based bowel cleansers used in preparation for colonoscopies and other procedures.

In December 2008, Fleet chose to voluntarily recall thousands of cases of the two medications after they were linked to kidney failure, including acute nephropothy, a buildup of calcium-phosphate crystals. Mr. McDaniel went as far as to suggest that Fleet might put the recalled medication back on the market.

Generally, the laxatives were found to be safe in a single dose, but when two doses were administered, even as directed, they were found, in some instances, to cause adverse effects in as little as two hours. Others lived for years without being aware of the damage.

Recent years have seen 38 lawsuits brought against Fleet. In June, those cases were consolidated in federal court. A class-action lawsuit is already under way in Canada.

Based in Lynchburg, Virginia, C.B. Fleet has been manufacturing the drugs for more than 100 years. Both are available over the counter without prescription.

Last December, competitor Salix Pharmaceuticals launched a Web site to provide information to health care professionals and consumers regarding bowel cleansers. Salix produces prescription-strength conoloscopy preps, including Visicol, MoviPrep and OsmoPrep.

The U.S. Food and Drug Administration set up a risk evaluation and mitigation strategy centered around Visicol and Osmoprep. The FDA has also required Fleet to include a boxed warning on the packaging for Fleet Phospho-soda EZ-Prep Bowel Cleansing System and Fleet Phospho-soda.

Common side-effects associated with taking ora sodium-phosphate drugs include abdominal bloating, abdominal pain, nausea and vomiting. Patients who experience complications or side-effects associated with bowel cleansers should contact their phsyician right away.

Nothing is more important than your health and it is always advisable to seek medical treatment when in doubt. Patients have a reasonable expectation that the medical care they receive will not harm them.

When serious injury or illness occurs due to the care of a doctor or nurse, be it directly or via medication, legal action might be appropriate. In some cases, victims might be entitled to reimbursement for medical expenses, recovery of lost wages due to missed work and even compensation for pain and suffering.

Only an experienced lawyer can properly evaluate a potential defective drug or medical malpractice case.

If you've been harmed by a prescription medication, such as an oral sodium phosphate, contact the defective drug attorneys of Keller & Keller.

James R. Keller
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Partner at Keller & Keller
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