Clinical Notes: FDA Issues Warning on Dialysis Fluid - MedPage Today PDF Print
By John Gever, Senior Editor, MedPage Today

Published: May 27, 2012

Some ingredients in hemodialysis solutions can produce metabolic alkalosis if providers are not careful about dosing, the FDA said. Also this week: POM is ruled not so wonderful in its advertising.

FDA: Watch for Dialysate Dosing Flubs

Healthcare workers administering dialysate concentrates -- the liquid solution used during hemodialysis procedures in patients with kidney failure -- should adjust dosing when the product contains acetate, citrate, and/or acetic acid, the FDA warned.

In the body, these chemicals may be converted into bicarbonate, potentially leading to metabolic alkalosis. This condition increased the risk of cardiopulmonary arrest, hypotension, arrhythmias, and serious hematologic abnormalities.

The agency advised healthcare providers to read the labels on diasylate concentrates carefully, and to pay attention to how the dialysis machine mixes the acid and base components.

The warning was issued in response to a complaint about alkali dosing errors during hemodialysis, the FDA said.

FTC Judge Slaps POM for Health Claims

An administrative law judge for the Federal Trade Commission (FTC) ruled that pomegranate juice maker POM Wonderful made unsupported health claims in its advertising.

Its ads had proclaimed that the juice products had powerful antioxidant properties that, in turn, made it effective in preventing cardiovascular disease, prostate cancer, and erectile dysfunction. For example, according to one of the firm's ads, "Medical studies have shown that drinking 8 oz. of POM Wonderful pomegranate juice daily minimizes factors that lead to atherosclerosis ... a major cause of heart disease."

The judge ordered the company to stop making such claims for the products. But he rejected an FTC request that the company be required to submit future ads to the agency for approval before publishing them, calling it "unnecessary overreaching."

That finding may bode poorly for an FDA push to require pharmaceutical companies to obtain its prior approval for direct-to-consumer ads for prescription drugs.

POM Wonderful said it planned to appealother parts of the ruling to the full FTC board.

Joint Realignment Helpful for Back Pain

A simple maneuver to realign the sacroiliac joint relieves pain in teen athletes reporting lower back pain, researchers said.

Pain in the sacroiliac joint is especially common in adolescent girls who play sports, according to a group at Washington University in St. Louis and its affiliated children's hospital.

Writing in the June issue of the Journal of Neurosurgery: Pediatrics, Ivan Stoev, MD, and colleagues described how the maneuver, which involves first pushing and then pulling on one leg while flexed at the hip and knee, led to "dramatic" improvement in 40 out of 48 patients, ages 10 to 21, who were identified as having sacroiliac joint misalignment.

Half the patients reported complete resolution of pain symptoms and about 25% reported some degree of improvement.

Work-Induced Asthma Remains Common

Nearly one in 10 adults with asthma contracted the condition on the job, according to a report from the National Institute of Occupational Safety and Health (NIOSH).

Federal survey data indicated that 9% of respondents reporting current asthma said they were told by a healthcare professional that it was work-related, NIOSH researchers said last week in Morbidity and Mortality Weekly Report.

The study found considerable variation between states, with fewer than 5% of asthmatic adults asserting an occupational origin in Arizona while neighboring Nevada had a prevalence of nearly 14%.

Causes were not a focus of the study, but the authors noted that employers can sometimes reduce the risk of work-related asthma. For example, elimination of powdered nonlatex gloves in the healthcare industry reduced rates of new asthma cases among doctors, nurses, and other health workers.

Radiation Leaks from Japan Nuke Bigger than Thought

The Fukushima nuclear power station in northeastern Japan spewed more than twice as much radiation into the environment as previously estimated during the week after it was wrecked in March 2011 by an earthquake and tsunami, its operator said.

Releases in the immediate aftermath totaled some 900 quadrillion becquerels, Tokyo Electric Power Co. officials said in a report released last week.

Previously, the country's nuclear regulatory agency had estimated that fewer than 400 quadrillion becquerels had been released.

What the new, higher estimate means for future health impacts remains unclear, as the radiation's distribution and resultant human exposures are still not known accurately.

Software Recall Designated Class I

A 3-year-old recall of software for calculating total parenteral nutrition (TPN) electrolytes has now been designated by the FDA as class I, indicating that the defective product has the potential to seriously injure or kill.

It involves Abacus software package from Baxa, which calculates TPN electrolyte dosing. It orders electrolytes either as a salt or as an elemental ion. The problem, according to the FDA, is that if the user enters a dosage based on one method and then configures the template using the other method, the resulting doses may be many times too small or too large, with potentially serious consequences.

Baxa identified the issue in 2009 and sent notices to customers with instructions for ensuring correct dosing.

According to the FDA, "over 90% of Abacus users have made corrective actions," but that suggests some customers are still using the software as originally distributed.

Abacus users who were unaware of the situation should contact Baxa for instructions. The company was recently acquired by Baxter Healthcare.

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John Gever

Senior Editor

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!

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