Navigation Links
FDA Puts Black-Box Warning on Bowel-Cleansing Drugs
Date:12/11/2008

Prescription products, used to prep for colonoscopy, may harm the kidneys, agency says; non-prescription treatments also will get warnings

THURSDAY, Dec. 11 (HealthDay News) -- Two prescription drugs used to cleanse the bowel before a colonoscopy may cause kidney damage, the U.S. Food and Drug Administration said Thursday.

The FDA said it would now require a black-box warning on the oral sodium phosphate products Visicol and OsmoPrep, alerting consumers about the risk of acute phosphate nephropathy -- a type of severe kidney injury.

"The FDA has received reports of 20 unique cases of kidney injury associated with the use of OsmoPrep," Dr. Joyce Korvick, deputy director of FDA's Division of Gastroenterology Products at the Center for Drug Evaluation and Research, said during an afternoon teleconference. "Of the reported cases, three were biopsy-proven cases of acute phosphate nephropathy. The onset of kidney injury in these cases varied, occurring in some within several hours of use of these products and in other cases up to 21 days after use."

The agency said it has told the products' manufacturer, Salix Pharmaceuticals of Morrisville, N.C., to develop what's called a risk evaluation and mitigation strategy, to distribute a medication guide for patients so they're aware of the risk of kidney injury, and to conduct a post-marketing clinical trial to gauge the risk of injury.

The FDA also said it was concerned about similar non-prescription treatments, such as Fleet Phospho-soda, made by C.B. Fleet Co. of Lynchburg, Va. These treatments also shouldn't be used for bowel cleansing, and will get new warnings. At lower doses, however, they are safe for use as laxatives, the FDA said.

Patients routinely take oral sodium phosphate products -- either prescription or over the counter -- to clean the intestines before a colonoscopy and other medical procedures.

"The FDA is recommending that consumers not use the over-the-counter preparations for bowel cleansing, but that these products be used under the direction of a physician," Korvick said.

She added that there are alternatives to these preparations that can be used for bowel cleansing, including GoLYTELY and HalfLytely Bowel Prep.

In 2006, the U.S. Food and Drug Administration put out an alert on oral sodium phosphate products, excluding OsmoPrep, recommending that they be "used with caution" among patients with impaired kidney function due to their high phosphate content.

The FDA said Thursday that oral sodium phosphate products shouldn't be used by children under 18 years of age, or in combination with other laxatives containing sodium phosphate. And the agency urged the following high-risk groups to use the products with caution:

  • people over 55 years of age,
  • people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and,
  • people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure), angiotensin receptor blockers (used to treat high blood pressure, heart or kidney failure), and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications).

Earlier this year, researchers reporting in the Archives of Internal Medicine said the risks of oral sodium phosphate solutions and some oral sodium phosphate tablets were rare but real, particularly for elderly patients.

Dr. Hemant K. Roy, an associate professor in the department of medicine at Evanston-Northwestern Healthcare in Illinois, writing in an accompanying editorial in the journal, described the findings as "quite alarming."

However, he stressed that warranted concerns about phosphate solutions shouldn't keep patients from undergoing colon cancer screening.

"Colonoscopies save lives," he said. "We know it works. So this should not dissuade people from doing one. I think we just need to be cautious about the type of preparation we use and who we give it to, so that an extraordinarily rare complication is avoided. And we have options, so there is a way to do that."

According to the American Cancer Society, colorectal cancer ranks third in the United States in terms of cancer diagnoses among both men and women. The organization estimates that about 150,000 people will develop the disease this year alone.

More information

For additional information on colonoscopies, visit the American Cancer Society.



SOURCES: Dec. 11, 2008, U.S. Food and Drug Administration teleconference with Joyce Korvick, M.D., MPH, deputy director of FDA's Division of Gastroenterology Products at the Center for Drug Evaluation and Research; Hemant K. Roy, M.D., associate professor, department of medicine, Evanston-Northwestern Healthcare, Evanston, Ill.


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Doctors raise questions, concerns about FDA suicide warning
2. Caraco Pharmaceutical Laboratories, Ltd. Responds to FDA Warning Letter
3. Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter
4. Wrinkle Fillers Need Better Label Warnings: FDA Panel
5. Quintet of proteins forms new, early-warning blood test before heart attack strikes
6. Spot the Warning Signs of Cancer in Your Pet
7. FairWarning(R) Announces New Privacy Surveillance Software Release
8. Paul Sullivans Legacy: An Early Warning Program for Detecting Melanoma Before Its Too Late
9. FDA Demands Tougher Warnings on Immunosuppressive Drugs
10. Antipsychotic Drug Use Up in Elderly Despite Warnings
11. FDA Expands Pepper Warning in Salmonella Outbreak
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Puts Black-Box Warning on Bowel-Cleansing Drugs
(Date:12/6/2016)... ... December 06, 2016 , ... Gateway ... now offering HIAC particle counting and sizing services for USP 788 and 789 ... the new service as a response to the needs of pharmaceutical and medical ...
(Date:12/6/2016)... (PRWEB) , ... December 06, 2016 , ... 'Tis the ... disrupt daily routines. That means it's also the season when eating healthy, staying active, ... with diabetes) on schedule is harder to do. , "Shopping trips, parties and ...
(Date:12/6/2016)... ... December 06, 2016 , ... ... the only authorized OSHA Training Institute Education Center headquartered in Northern California, has ... focused on providing occupational safety and health training to public sector employees. , ...
(Date:12/5/2016)... ... December 05, 2016 , ... ... Surgery, is excited to announce the arrival of the newest Sciton laser in ... the ability to use tunable non-ablative and ablative wavelengths for exceptional results. Outperforming ...
(Date:12/5/2016)... ... 05, 2016 , ... Researchers at Johns Hopkins All Children’s Hospital want to ... Over the course of three years, researchers will study concussions and changes in brain ... equipped with special sensors, will track the location and force of the hit. The ...
Breaking Medicine News(10 mins):
(Date:12/5/2016)... Dec. 5 2016 United Kingdom Ophthalmic ... GlobalData,s new report, "United Kingdom Ophthalmic Diagnostic ... data on the United Kingdom Ophthalmic Diagnostic Equipment ... US dollars, volume (in units) and average prices ... (OCT), Retinal Ultrasound Imaging Systems, Corneal Topography Systems, ...
(Date:12/5/2016)... Dec. 5, 2016   Mallinckrodt Pharmaceuticals (NYSE: ... company, today announced that it received a perfect score ... (CEI), a national benchmarking survey and report on corporate ... transgender (LGBT) workplace equality, administered by the Human Rights ... major U.S. businesses which also earned top marks this ...
(Date:12/5/2016)... Dec. 5, 2016  Cornerstone Pharmaceuticals, Inc., a ... data from two Phase I trials evaluating its ... 58th annual meeting of the American Society of ... . The two datasets show encouraging efficacy ... leukemia (AML) and T-cell non-Hodgkin,s lymphoma (T-cell NHL), ...
Breaking Medicine Technology: