Navigation Links
Grandfathered drug for high potassium has no proven benefit
Date:3/9/2010

For more than half a century, products containing ion exchange resins have been used in patients with dangerously high levels of potassium. However, there is no convincing evidence that these products are actually effective, according to an article appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). "We suspect that if ion exchange resins were introduced today, they would not be approved," comments Richard H. Sterns, MD (Rochester General Hospital, University of Rochester School of Medicine and Dentistry, Rochester, NY).

High potassium levels (hyperkalemia) are a potentially life-threatening problem, commonly occurring in patients with kidney disease. Ion exchange resins, mixed with a cathartic called sorbitol, have long been used to treat hyperkalemia. Millions of doses of this product are prescribed every year in the United Statesyet it has never been studied with controlled trials to prove it works. Explains Sterns, "these agents came into widespread use in 1958four years before drug manufacturers were required to prove the effectiveness of their products before gaining FDA approval. Their approval was essentially 'grandfathered.'"

Last year, the FDA issued a warning against giving ion exchange resins with sorbitol, based on reported cases of potentially fatal bowel injury. Yet pre-mixed preparations of the resin with sorbitol are still marketed and widely used. Sterns asks, "If ion exchange resins were presented to the FDA today, with the data available, would the agency rule them safe and effective?"

The answer, according to Sterns, based on a review of the available data is "probably not." "We found no rigorous scientific evidence that ion exchange resins are effective in ridding the body of excess potassium," says Sterns. "In fact, we found some evidence showing that, on rare occasions, they might be harmful."

"We found no evidence that would meet modern standards for drug approval," Sterns and coauthors conclude. They call for further studies to weigh the harms versus benefits of these products. Meanwhile, they believe that doctors should first try other alternatives to managing high potassium levels, "before turning to these largely unproven and potentially harmful therapies."


'/>"/>

Contact: Shari Leventhal
sleventhal@asn-online.org
202-416-0658
American Society of Nephrology
Source:Eurekalert  

Related medicine news :

1. Potassium-Rich Foods Do a Heart Good
2. Free Pills from Government Boost Potassium Iodide Sales
3. Pennsylvania Health Department Distributing Potassium Iodide to People Living, Working Near Nuclear Power Plants
4. Xanodyne Receives Approval From the U.S. Food and Drug Administration for ZIPSOR(TM) (diclofenac potassium) Liquid Filled Capsules
5. Sodium, Potassium Intake Tied to Heart Disease
6. Potassium loss from blood pressure drugs may explain higher risk of adult diabetes
7. Lack of Potassium Linked to High Blood Pressure
8. Low potassium linked to high blood pressure
9. Unilever Unveils Promise(R) SuperShots(R) for Blood Pressure, the First Functional Shot to Increase Daily Potassium Intake to Help Reduce the Risk of High Blood Pressure
10. Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules
11. A drug-sensitive traffic cop tells potassium channels to get lost
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Grandfathered drug for high potassium has no proven benefit
(Date:5/24/2017)... ... , ... Rob Lowe is a sought after actor, and also serves as ... public important topics from all aspects of life, and a new segment is being ... and ankles. , Podiatry is essential to people’s overall well-being, and if viewers have ...
(Date:5/24/2017)... , ... May 24, 2017 , ... ... fluoride (PVDF) based sleep diagnostics sensors, announced today it had completed the first ... of a mix of domestic and rest of world (ROW) authorized dealers specializing ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... medical device sectors, today announced the winners of its 3rd Annual ELITE Awards. ... most influential people in the healthcare industry today. , Out of more than ...
(Date:5/23/2017)... (PRWEB) , ... May 23, 2017 , ... ... certification body for exercise professionals, is pleased to announce the organization’s Certified Strength ... , The NCSF Certified Strength Coach (CSC) program validates the competency of qualified ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... educating patients on peri-implantitis in Las Vegas, NV, and the importance ... custom gum disease consultation and leading care for peri-implantitis, with or without a ...
Breaking Medicine News(10 mins):
(Date:5/8/2017)... MACRA replaces the outdated sustainable growth ... reimbursement. Black Book Research crowdsource-surveyed 8,845 physician practices from ... Market for MIPS Compliance Technology is Booming ... 3 or more clinicians seek to buy Merit-Based Incentive ... magnitude of the changes, the hunt is on for ...
(Date:5/6/2017)... , May 5, 2017   Provista , a ... more than 200,000 customers, today announced Jim Cunniff ... wealth of executive and business experience to Provista, including most ... pharmacy in California . He assumed his ... "Jim is a great fit for Provista," says Jody ...
(Date:5/6/2017)... , May 5, 2017  Hill-Rom Holdings, Inc. (NYSE: ... approximately 100,000 square feet to its Welch Allyn campus. ... its commitment to bring more than 100 new jobs ... Welch Allyn has maintained a significant presence for more ... these new positions, a large portion of which will ...
Breaking Medicine Technology: