By; LISA R. WILSON

Federal health officials announced Thursday they will add the strongest safety warning, a black box label, to prescription drugs used to cleanse the bowel before colonoscopies. The new warning label will apply to Visicol and OsmoPrep tablets, known as oral phosphate products, made by Salix Pharmaceuticals. The black box label warns patients who suffer from dehydration and kidney disease, or those who take medications that affect the kidneys, to take strong precautions when using these medicines.

The FDA said that it has received more than 20 reports of a rare but serious form of kidney failure among patients taking the drugs. The FDA first warned doctors and patients about potential kidney risks with the medications in 2006.

The FDA said they are also concerned about the kidney risks from over-the-counter bowel-cleansing medications, such as Fleet Phospho-soda, made by C.B. Fleet Company Inc. While non-prescription products cannot receive black boxed warnings, FDA officials said they plan to require stricter labeling on over-the-counter phosphate drugs.

A person injured by a defective or dangerous product may be eligible to file a lawsuit for product liability. Damages can be recovered under one of the following categories: strict products liability; negligence or breach of warranty.

If you or a loved one has taken Visicol or OsmoPrep, please visit with your physician immediately. If you have suffered kidney damage from taking these drugs, you may be eligible for compensation. To learn more, contact a qualified personal injury attorney in your area today.

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https://blog.lawinfo.com/2008/12/20/fda-gives-bowel-cleaning-drugs-a-black-box-warning
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