Category

Recalls 1606 articles

New, less invasive colonoscopy more tolerable but less reliable

A new medical procedure to find polyps in the colon may hold promise, but kinks still need to be worked out, according to a report in MedPage Today. The new procedure, called a capsule colonoscopy, offers an alternative to the traditional colonoscopy in which a patient undergoes a bowel cleansing process before going under local anesthesia and having a flexible telescopic camera passed through the rectum and bowel. ... Read More

FDA issues black box warning on OSP products

On December 11, 2008, the Food and Drug Administration (FDA) issued a "black box warning" to consumers and health care professionals that a rare but serious form of kidney failure, acute phosphate nephropathy, had been associated with the use of prescription oral sodium phosphate (OSP) products Visicol and Osmo Prep, both made by Salix Pharmaceuticals. The products are routinely prescribed for bowel cleansing prior to colonoscopy, radiographic procedures and surgery. Acute phosphate nephropathy is a rare but serious adverse event that is often permanent and may require chronic dialysis. The FDA expressed equal concern about the risks associated with over-the-counter (OTC) bowel clearing products such as Fleet Phospho-soda and Fleet Accu-Prep solutions. ... Read More

FDA issues warning on Oral Sodium Phosphate products

On December 11, 2008, the Food and Drug Administration (FDA) issued a "black box warning" to consumers and health care professionals that a rare but serious form of kidney failure, acute phosphate nephropathy, had been associated with the use of prescription oral sodium phosphate (OSP) products Visicol and Osmo Prep, both made by Salix Pharmaceuticals. The FDA expressed equal concern about the risks associated with over-the-counter (OTC) bowel clearing products such as Fleet Phospho-soda and Fleet Accu-Prep solutions. ... Read More

C.B. Fleet issues recall of its OTC phosphate products

In response to the Food and Drug Administration's stern safety warning last December about the risk of a rare form of kidney failure associated with two oral sodium phosphate medicines prescribed to cleanse the colon prior to a colonoscopy, C.B. Fleet Company Inc. announced a voluntary recall of its over-the-counter Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System. ... Read More