(PRWEB) June 18, 2012

Public Health Watchdog, a media outlet created to protect and warn consumers about the dangers of defective products, is alerting the public about metabolic alkalosis with Fresenius Medical Care’s GranuFlo and NaturaLyte dialysis products, which can lead to heart problems and other potentially fatal complications. According to the New York Times, the company acknowledged the dangers in an internal memo last year, but failed to disclose the information to the FDA, its consumers or the public. [nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?emc=tnt&tntemail0=y]

Dialysis is a procedure that replaces the function of the kidneys by filtering toxic waste products out of the blood; a number of different solutes are used to maintain a healthy balance. One of these substances is bicarbonate, an alkaline chemical used to neutralize any excess acidity in the blood. According to the New York Times, the issue with GranuFlo and NaturaLyte is that they produce more bicarbonate than their competitors, which may lead to excessively high alkaline levels, or metabolic alkalosis. Metabolic alkalosis can increase the risk of serious complications, such as:

•     Sudden Cardiac Arrest
•     Sudden Heart Attack
•     Hemodialysis cardiac arrest
•     Hemodialysis cardiopulmonary arrest
•     Stroke
•     Death
•     Arrhythmia
•     Altered mental status (confusion)
•     Low blood pressure

Fresenius Medical Care addressed these risks in an internal memo dated November 4, 2011, but did not warn its consumers or the public about the issue until March, after it was questioned by the FDA. The memo stated that 941 patients experienced cardiac arrest in Fresenius clinics in 2010, and found that that elevated bicarbonate levels resulted in a six fold increased risk of cardiac arrest. “In light of these troubling findings” doctors should adjust blood alkalinity accordingly, the memo said.

Fresenius finally issued a letter in late March, after the FDA questioned them about the matter. In addressing the bicarbonate alkalosis issue, the letter said that “Recent analyses performed using FMCNA hemodialysis (HD) patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit.” [fmcna.com/fmcna/idcplg?IdcService=GET_FILE&allowInterrupt=1&RevisionSelectionMethod=LatestReleased&Rendition=Primary&dDocName=PDF_300045654]

According to the New York Times, the legality of the issue requires further inquiry but many feel that their conduct was nonetheless unethical and put patients at risk. Matthew McCauley, attorney, said “Fresenius was clearly aware of these issues, but chose to risk patient safety by withholding that information from the public.” Chief medical officer Dr. Thomas F. Parker of Renal Ventures, which uses Fresenius products, expressed similar sentiments to the New York Times, “If the data was sufficient to warn their doctors, then all users of the product should have been made aware of it.”

In late May, the FDA warned the public about bicarbonate alkalosis in hemodialysis, asking physicians to take into account “the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates”. The agency says that when these substances metabolize to bicarbonate, “This can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.”
[fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm]

About Public Health Watchdog
Public Health Watchdog is a media outlet created to provide consumers with up-to-date information about defective drugs and medical devices that could endanger their health. For more information on Clear Care contact lens solution, as well as other dangerous drugs and medical devices, please visit Public Health Watchdog today.

Contact:
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Study Highlights: , Jun 18, 2012 (GlobeNewswire via COMTEX) -- During 10 years ending in 2006, hospitalizations for children with high blood pressure increased dramatically. -- Related hospital charges to treat them also soared. -- Researchers suggest healthcare providers address healthy lifestyle habits during children's well visits to reduce risk of hypertension.

EMBARGOED UNTIL 3 pm CT/4 pm ET, Monday, June 18, 2012

DALLAS, June 18, 2012 (GLOBE NEWSWIRE) -- Hospitalizations for children with high blood pressure and related charges dramatically increased during 10 years ending in 2006, according to a study published in the American Heart Association journal Hypertension.

This nationally-based study is the first in which researchers examined hypertension hospitalizations in children.

While researchers expected a rise in hospitalizations due to the increased frequency of high blood pressure in children, "the economic burden created by inpatient childhood high blood pressure was surprising," said Cheryl Tran, M.D., study lead author and pediatric nephrology fellow in the Department of Pediatric Nephrology at the University of Michigan in Ann Arbor.

Researchers obtained discharge records from the Healthcare Cost and Utilization Project (HCUP) Kids' Inpatient Database from 1997, 2000, 2003 and 2006.

They found:

        
          --  Pediatric hypertension-related hospitalizations in the United States
              nearly doubled, from 12,661 in 1997 to 24,602 in 2006.
          --  Charges for inpatient care for hypertensive children increased by 50
              percent, reaching an estimated $3.1 billion. That does not include
              outpatient charges, a figure that remains unknown nationwide.
          --  The most significant increases in healthcare charges were for children
              with hypertension and end stage kidney disease.
          --  Average length of stay for children with hypertension was double that of
              children with other illnesses, eight days compared to four days.
        
        
        

Researchers hypothesize that the increasing hospitalizations may in part be due to the rise in childhood obesity.

Children hospitalized with hypertension were more likely to be older than 9 years, male, African-American and treated in a teaching hospital.

Overall, the most common diagnoses for hospitalized children were pneumonia, acute appendicitis and asthma. When hypertension was the primary diagnosis, convulsive disorder, headache, obesity and systemic lupus erythematosus were the most common secondary diagnoses.

When high blood pressure was in any diagnoses, the most common primary diagnoses were lupus, complications of kidney transplant, pneumonia and acute proliferative glomerulonephritis, a condition in the kidney that causes inflammation that can result in hypertension.

Physicians should address healthy lifestyle habits during children's well visits to reduce hypertension, Tran said.

"A child with high blood pressure is at increased risk for having high blood pressure in adulthood and the heart and stroke risks that come with that diagnosis," she said.

Hypertension is present in 1 percent to 3 percent of children in the United States.

Among children ages 2 to 19 years, 31.7 percent are overweight (23.6 million) and 16.9 percent are obese (12.6 million), according to American Heart Association statistics.

Co-authors are Brett J. Ehrmann, B.A.; Kassandra L. Messer, B.A.; Emily Herreshoff, B.A.; Amber Kroeker, M.P.H.; Larysa Wickman, M.D.; Peter Song, Ph.D.; Nicole Kasper, M.P.H. and Debbie S. Gipson, M.D. Author disclosures are on the manuscript.

A research training grant in pediatric nephrology funded the study.

Learn more about high blood pressure in children. Learn more about preventing and managing childhood obesity and reducing sodium in the diets of American children.

Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding .

NR12-- 1085 (Hypertension/Tran)

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SOURCE: American Heart Association

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