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:2/13/2016)... ... February 13, 2016 , ... In the early or “honeymoon” stage ... to perfection, go out of their way to be romantic, and may exaggerate a ... look at any online dating profile. , A recent study from Queendom.com ...
(Date:2/12/2016)... Opelousas, LA (PRWEB) , ... February 12, 2016 , ... ... of St. Landry and Evangeline Parishes. The purpose of these scholarships is to ... to encourage those individuals to seek employment within these two parishes. , “We ...
(Date:2/12/2016)... ... February 12, 2016 , ... Fixed Dose Combination Drug Development: ... EST, http://www.fdanews.com/fixeddosecombination , Fixed dose combination products are ... attention from all stakeholders in the development of new chemical entities. , However, ...
(Date:2/12/2016)... ... 2016 , ... T.E.N., a technology and information security executive ... Awards 2016. Finalists and winners of the ISE® Awards for both Executive and ... Gala on March 15, 2016 at the Westin Peachtree Plaza, Atlanta. , ...
(Date:2/12/2016)... ... 12, 2016 , ... Fisher House Foundation Chairman and CEO Kenneth Fisher joined ... Support Alliance president Scott Bensing, and Peggy Kearns Director, VA Southern Nevada Healthcare System ... This will be the first Fisher House in Nevada, and will provide free ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... , Feb. 11, 2016 Potrero Medical, Inc., the ... to announce the appointment of George M. Rapier, III ... San Antonio, TX , WellMed is one of the ... patients and HMO members in Texas ... 1990 out of his own internal medicine practice, he has ...
(Date:2/11/2016)... -- MiMedx Group, Inc. (NASDAQ: MDXG ), the leading ... birth tissues, human skin and bone, and patent-protected processes ... and therapies, announced today that it will present at ... New York , NY.  Parker H. ... , Chief Financial Officer and Chris Cashman , ...
(Date:2/11/2016)...  AfterPill.com is reporting that this week,s Centers for ... women who are at risk of unintended pregnancy impacts ... raises the risks of unprotected sex in particular.  ... to the Guttmacher Institute, there are 43 million women ... who have sex without the intention of becoming pregnant.  ...
Breaking Medicine Technology: