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Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
What you should know
According to the FDA, an inappropriate prescription for these drugs could lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may lead to metabolic alkalosis, which makes a patient at significant risk for low blood pressure, low blood potassium (hypokalemia), low blood oxygen (hypoxemia), high blood carbon dioxide (hypercapnia) and irregular heartbeat (cardiac arrhythmia). If not properly treated, these side effects could lead to a potentially fatal heart attack (cardiopulmonary arrest).
Dialysate products such as NaturaLyte and NaturaLyte GranuFlo are solutions prescribed by physicians for use in the treatment of acute and chronic kidney failure during the hemodialysis procedure. The dialysate solution is used in combination with the hemodialysis machine and dialyzer to remove wastes from the blood. Dialysate acid concentrate can contain acetic acid, acetate or citrate, which can be converted in the body to bicarbonate – potentially contributing to metabolic alkalosis.
The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. The FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis
NaturaLyte and GranuFlo increase the risk of heart attack and sudden death by heart attack six times. Fresenius knew there were injuries and dangers linked to these dialysis products, but didn’t warn patients and physicians until 2012.
Potential medical risks include:
- Hemodialysis cardiac arrest
- Altered mental status (confusion)
- Cardiopulmonary arrest
- Heart problems
- Metabolic alkalosis
- Low blood pressure
- Sudden myocardial infarction or heart attack
What you can do
Patients and healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.htm.
The Judicial Panel on Multidistrict Litigation has asked to consolidate cases brought against Fresenius Medical Care North America in the U.S. District Court for the District of Massachusetts for coordinated or consolidated pretrial proceedings; the motion was brought by the plaintiffs in two cases. The plaintiffs are the survivors of dialysis patients who suffered cardiopulmonary arrest allegedly as a result of dialysis treatment with dialysate products Naturalyte GranuFlo® Acid Concentrate and Naturalyte® Liquid Acid Concentrate.
To date, 11 GranuFlo actions have been filed in federal district courts.
The FDA explains its recall for Fresenius Medical Care North America NaturaLyte Liquid Acid Concentrate and NaturaLyte GranuFlo (powder) Acid Concentrate because inappropriate prescription may cause serious illness or death. Read more here.
Obtain a Free NaturaLyte or NaturaLyte GranuFlo Lawsuit Evaluation from Showard Law Firm. If you or a loved one has taken NaturaLyte or NaturaLyte GranuFlo and experienced serious heart problems or other life-threatening complications, please contact your health care professional first to communicate your concerns and decide together the best course of treatment. It’s important that you take care of your health first and foremost. After speaking with your doctor, if you feel you experienced or are experiencing serious heart problems or other life threatening complications due to NaturaLyte or NaturaLyte GranuFlo, please call us toll free at 1-866-307-2147 or locally at (520) 622-3344.
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