Grandfathered drug for high potassium has no proven benefit

Mar 09, 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 . 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 were required to prove the effectiveness of their products before gaining . 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 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 ," 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."

Explore further: Anti-cholinergic drugs impair physical function in elderly patients

More information: The article, entitled "Ion-Exchange Resins for the Treatment of Hyperkalemia: Are They Safe and Effective?" is available online, doi:10.1681/ASN.2010010079

add to favorites email to friend print save as pdf

Related Stories

Brain cell potassium regulator is studied

Aug 17, 2006

U.S. scientists say proteins regulating brain-cell activity by controlling potassium ion flow behave more like volume controls than on-off switches.

Recommended for you

FDA to start regulating lab-developed tests

Jul 31, 2014

(AP)—The Food and Drug Administration announced Thursday it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

User comments : 0