If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Study Challenges Efficacy of Ion Exchange Resins for Hyperkalaemia WASHINGTON, DC -- March 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, New York. Hyperkalaemia commonly occurs in patients with kidney disease. Ion exchange resins, mixed with a cathartic called sorbitol, have long been used to treat hyperkalaemia. 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. “These agents came into widespread use in 1958, 4 years before drug manufacturers were required to prove the effectiveness of their products before gaining FDA approval,” explains Dr. Sterns. “Their approval was essentially ‘grandfathered.’” Last year, the US Food and Drug Administration 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. “If ion exchange resins were presented to the FDA today, with the data available, would the agency rule them safe and effective?” poses Dr. Sterns. The answer, based on a review of the available data is “probably not,” answers Dr. Sterns. “We found no rigorous scientific evidence that ion exchange resins are effective in ridding the body of excess potassium. 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,” Dr. Sterns and his study co-authors 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.” SOURCE: American Society of Nephrology
|
