Featured Research

from universities, journals, and other organizations

Grandfathered drug for high potassium has no proven benefit, study finds

Date:
March 9, 2010
Source:
American Society of Nephrology
Summary:
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 a new study.

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).

Related Articles


"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 States -- yet it has never been studied with controlled trials to prove it works. Explains Sterns, "these agents came into widespread use in 1958 -- four 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."

Study co-authors are Maria Rojas, Paul Bernstein, and Sreedevi Chennupati, all of Rochester General Hospital.


Story Source:

The above story is based on materials provided by American Society of Nephrology. Note: Materials may be edited for content and length.


Journal Reference:

  1. Sterns et al. Ion-Exchange Resins for the Treatment of Hyperkalemia: Are They Safe and Effective? Journal of the American Society of Nephrology, 2010; DOI: 10.1681/ASN.2010010079

Cite This Page:

American Society of Nephrology. "Grandfathered drug for high potassium has no proven benefit, study finds." ScienceDaily. ScienceDaily, 9 March 2010. <www.sciencedaily.com/releases/2010/03/100309142751.htm>.
American Society of Nephrology. (2010, March 9). Grandfathered drug for high potassium has no proven benefit, study finds. ScienceDaily. Retrieved October 30, 2014 from www.sciencedaily.com/releases/2010/03/100309142751.htm
American Society of Nephrology. "Grandfathered drug for high potassium has no proven benefit, study finds." ScienceDaily. www.sciencedaily.com/releases/2010/03/100309142751.htm (accessed October 30, 2014).

Share This



More Health & Medicine News

Thursday, October 30, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Mind-Controlled Prosthetic Arm Restores Amputee Dexterity

Mind-Controlled Prosthetic Arm Restores Amputee Dexterity

Reuters - Innovations Video Online (Oct. 29, 2014) A Swedish amputee who became the first person to ever receive a brain controlled prosthetic arm is able to manipulate and handle delicate objects with an unprecedented level of dexterity. The device is connected directly to his bone, nerves and muscles, giving him the ability to control it with his thoughts. Matthew Stock reports. Video provided by Reuters
Powered by NewsLook.com
Google To Use Nanoparticles, Wearables To Detect Disease

Google To Use Nanoparticles, Wearables To Detect Disease

Newsy (Oct. 29, 2014) Google X wants to improve modern medicine with nanoparticles and a wearable device. It's all an attempt to tackle disease detection and prevention. Video provided by Newsy
Powered by NewsLook.com
Can Drinking Milk Lead To Early Death?

Can Drinking Milk Lead To Early Death?

Newsy (Oct. 29, 2014) Researchers in Sweden released a study showing heavy milk drinkers face an increased mortality risk from a variety of causes. Video provided by Newsy
Powered by NewsLook.com
Obama: The US Will Not 'run and Hide' From Ebola

Obama: The US Will Not 'run and Hide' From Ebola

AP (Oct. 29, 2014) Surrounded by health care workers in the White House East Room, President Barack Obama said the U.S. will likely see additional Ebola cases in the weeks ahead. But he said the nation can't seal itself off in the fight against the disease. (Oct. 29) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

    Environment News

    Technology News



    Save/Print:
    Share:

    Free Subscriptions


    Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

    Get Social & Mobile


    Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

    Have Feedback?


    Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
    Mobile: iPhone Android Web
    Follow: Facebook Twitter Google+
    Subscribe: RSS Feeds Email Newsletters
    Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins