Articles Posted in GranuFlo

Plaintiffs continue to come forward, accusing Fresenius Medical Care of failing to inform patients about the risks involved with GranuFlo. This medical powder used in kidney dialysis treatment to help clean the blood of patients. Now, there are around 5,500 GranuFlo injury cases, many of which were filed in U.S. District Court in Boston and Middlesex Superior Court in Massachusetts. Fresenius is based in Waltham, MA.

GranuFlo has been linked to a greater risk of heart attack and metabolic alkalosis, which involves the body fluids having too much bicarbonate in the blood. Metabolic alkalosis can lead to more serious health issues, including hypoxemia, hypokalemia, high blood pressure, and cardiac arrhythmia.

Many of the Massachusetts defective medical device plaintiffs have noted that when Fresenius eventually told dialysis clinicians about the risks, it initially chose to only notify its own clinics. Their claims point to a company memo that Fresenius sent to its clinicians warning that the powder may cause cardiac event-related risks. Product labeling, which can lead to dosing errors, appears to be the main cause of this problem.

Our Boston GranuFlo attorneys represent victims and their families with claims against Fresenius Medical Care for health complications involving GranuFlo, a dry acid product used in Dialysis treatments. Fresenius Medical Care is the largest dialysis operator in this country and the leading supplier of dialysis machines and disposal products used in other clinics. Now, however, there are many reports claiming that GranuFlo ups the risk of low blood pressure, heart attack, metabolic alkalosis, stroke, and death.

Granuflo is used to lower acid in patients on dialysis. It converts to bicarbonate in the bloodstream, which is supposed to neutralize the acid found in the blood. Because GranuFlo has more of an ingredient that becomes a bicarbonate than other dialysates, this can up the chance of a bicarbonate overdose.

Last year, the FDA recalled GranuFlo following an urgent notification by Fresenius warning of the possible risk of heart attack. In its Class I recall, the government regulator said that inappropriate dosing of GranuFlo and NaturaLyte, which also is made by Fresenius and used to reduce acid in dialysis patients, were linked to high bicarbonate levels in the blood, which could cause metabolic alkalosis, a huge risk factor for serious cardiovascular issues, including cardiac arrhythmia, which may result in cardiopulmonary arrest and sudden cardiac death. (The New York Times previously reported that while Fresenius notified its clinics of the elevated heart risks in November 2011, recommending that doctors modify their dosage of the two acids to decrease the risk, the manufacturer did not warn clinics outside its ownership of the possible complication until the following year in March.)

Every week, about 400,000 Americans undergo dialysis treatments, sometimes more than once, for their kidney-related complications. Many of these treatments use GranuFlo, which is made by Fresenius Medical Care, the biggest dialysis center operator in the US and the number one supplier of disposal products and dialysis machines used in other clinics. Unfortunately, there have been hundreds of reports linking GranuFlo with serious risks of heart attack, stroke, low blood pressure, metabolic alkalosis, and death.

In Massachusetts, please contact our Boston GranuFlo dialysis injury lawyers at Altman & Altman LLP and request your free case evaluation. Our Boston drug injury law firm represents patients with product defects cases and medical malpractice claims.

It was last year that the US Food and Drug Administration announced the recall of GranuFlo and Naturalyte, another Fresenius dialysis product that has been linked to the same serious health risks. GranuFlo is an acid concentrate powder while Naturalyte is a liquid. The two medications have an ingredient that the body can turn into bicarbonate. While other dialysis meds also have this ingredient, these Fresenium products have more, which may be a reason their patients are more at risk of developing alkalosis, which is a condition linked to a greater risk of cardiovascular conditions. The recall, a Class 1, is the most serious level of recall that the government only puts out when it believes that the risk of serious side effects or death is high.

Earlier this year, the Food and Drug Administration issued a Class 1 recall for GranuFlo, an acid concentrate used in dialysis, which is a medical technique that helps eliminate waste materials from the kidneys when a patient can no longer do so without assistance. If you or someone you love has suffered serious injury or health complications from GranuFlo, please contact the drug injury law firm of Altman & Altman, LLP today.

A Class 1 recall means that GranuFlo is considered to be unsafe enough that it may cause serious health issues or even death. Serious side effects linked to this compound include:

• Heart attack • Heart ailments • Very low blood pressure • Lowered potassium levels • Metabolic alkalosis • Stroke • Decreased oxygen levels in the blood • Cardiopulmonary arrest • Higher blood levels of CO2 • Death