News Tagged ‘black box warning

Virtual colonoscopy shows promising results

A study by a group of Italian researchers shows that virtual colonoscopies that use computer tomography scans are almost as effective at detecting tumors and precancerous lesions as standard colonoscopies, which requires threading a camera through the colon. The study, published in The Journal of the American Medical Association, suggests that the new procedure may offer an alternative to people who are too embarrassed or afraid to undergo a standard colonoscopy.

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Pauly Polyp encourages regular colon screenings

Nobody enjoys colonoscopies, but they save lives. Regular can detect polyps even before they become cancerous. It is recommended that people begin beginning at age 50, or earlier if they have a family history or are exhibiting symptoms such as blood in the stool. But how can you convince someone he needs to have a colonoscopy? Just have Pauly Polyp do the asking.

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Lawsuits mount against maker of over-the-counter bowel cleanser

fleet product boxes 150x150 Lawsuits mount against maker of over the counter bowel cleanserThe Food and Drug Administration (FDA) black box warning on oral sodium phosphates (OSPs) came late last year, but as early as 2003, doctors were beginning to make the link between OSP pills and solutions used to clear the bowel before colonoscopies and serious and permanent kidney injuries. As more and more reports of kidney damage and even complete kidney failure began to pour in to the FDA, the agency finally issued a mild warning in 2005. The black box warning on prescription OSP products would come three years later, after 21 more reports of serious kidney injuries. Soon after that FDA warning, C.B. Fleet quickly pulled its over-the-counter OSP products off the market.

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Oprah, Oz sue colon cleanse company over false advertising

Internet commercials for featuring the images, names and voices of Oprah Winfrey and her friend Dr. Oz are a hoax, says Winfrey and Oz, and they have filed a lawsuit in New York Federal Court to take the ads down, according to TMZ. The lawsuit claims the company is trying to cash in on the false premise that the products have been tested or recommended by Winfrey and/or Oz when they, in fact, have not. Winfrey and Oz claim the company, which sells products such as Colon Pro CleansePower Colon Cleanse and Colon Max, “turn out to be credit card scams or other fraudulent schemes.”

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Humor takes the anxiety out of colonoscopies

Colonoscopies are serious business. The procedure involves sending a small camera inside the colon to search for abnormalities, including colon or rectal cancers, also known as colorectal cancer. Regular can find polyps even before they become cancerous. By removing those polyps, one can literally dodge colorectal cancer.

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Canada orders makers of common OTC laxatives to re-label

OSP products incl fleet 150x120 Canada orders makers of common OTC laxatives to re label Health Canada has ordered manufacturers of over-the-counter oral sodium phosphates (OSP), such as Fleet Phospho-Soda, to either re-label the products to remove any mention of bowel cleansing, or remove the products completely from the Canadian market.

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Understanding the symptoms of colorectal cancer

Colorectal cancer, or cancers of the colon or rectum, is the third most common cancer diagnosed in both men and women and the second leading cause of cancer-related deaths in the United States among men and women combined, according to the American Cancer Society. The average person has about a 1 in 19 risk of developing the disease over his lifetime. Detected early, the disease can be curable. The best defense is regular screenings. Regular colonoscopies are recommended beginning at age 50, or sooner for those with a family history or exhibiting symptoms.

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Vaccine may eliminate need for routine colon screenings

Clinical trials of a vaccine designed to trigger the body to attack a protein linked to colon cancer are currently being conducted by scientists at the University of Pittsburgh School of Medicine. The vaccine activates the immune system to target a defective protein which is prevalent in colorectal cancer tissue and other precancerous tissues. Researchers hope, if proven successful, the vaccine may eliminate the need for repeated in high-risk patients. These patients tend to have multiple precancerous polyps, called advanced adenomas, in their intestines. Routine colonoscopies look for signs of recurrence of the polyps.

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Colorectal cancer rates rise among young adults

While overall colorectal cancer rates are steadily decreasing, colorectal cancer rates among younger patients are on the rise, according to data collected from the 13 Surveillance, Epidemiology, and End Results (SEER) cancer registries nationwide and studied by the American Cancer Society.

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Severe kidney injury linked to use of OSP products

fda logo 150x150 Severe kidney injury linked to use of OSP productsOn December 11, 2008, the Food and Drug Administration (FDA) issued a safety alert calling for a black box warning on prescription oral sodium phosphate (OSP) products used to prepare the bowel prior to colonoscopies following reports of a serious form of kidney injury in patients who had taken OSP products.

The black box warning fell on Salix  Pharmaceuticals’ prescription OSP brands Visicol and Osmo Prep, and serious warning was placed on over-the-counter OSP products such as Fleet Phospho-soda and Fleet Accu-Prep. The serious adverse event that was occurring in patients repeatedly over the years was a serious form of kidney injury now known as acute phosphate nephropathy.

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