GranuFlo and Naturalyte are powder or liquid acid concentrates that are administered to diabetics and other patients during dialysis.
FDA Recall of Fresenius GranuFlo and Naturalyte
The FDA issued a Class 1 recall, the most serious of the recalls, due to the potential for life-threatening injury or death. An internal communication of the manufacturer of the concentrates, Fresenius, indicated patients had a 6 times greater risk of suffering a heart attack or other complications requiring immediate and drastic medical intervention. In 2010, 941 Fresenius patients died and over 130,000 were put at risk. Fresenius Dialysis Centers treats more than 150,000 patients with these concentrates each year, and their products, including GranuFlo and Naturalyte, are used by other dialysis centers.
Injured patients and their families are suing Fresenius for failing to warn patients and doctors of the significant risks. The first cases are scheduled to begin in January, 2013. If you have been affected by Granuflo or Naturalyte, or experienced the symptoms or conditions below and are not sure if you were given these concentrates during dialysis, contact the defective drug attorneys at the Harman Law Firm immediately at 404-554-0777 or fill out the contact form on this site to learn your rights and if you are eligible to file a lawsuit. We can help ; your current and future health could be at significant risk.
According to the FDA: “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. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.”
Risks of GranuFlo and Naturalyte
Administration of GranuFlo and Naturalyte may contribute to metabolic alkalosis, an overdose of bicarbonate in the blood which is a significant risk factor associated with injuries or conditions that can lead to injury or death caused by:
- low blood pressure
- can cause stroke, heart attack, death
- drop in potassium levels in the blood which can affect muscle and nerve response
- abnormally law oxygen in the blood, potentially causing a lack of oxygen to the brain which can lead to brain damage or death. The brain can be affected as soons as five minutes after oxygen deprivation
- excessive carbon dioxide in the blood, which can cause fainting, stroke, brain damage and other complications
- cardiac arrhythmia
- heart attack/heart injury which, if not appropriately and rapidly treated, may lead to death
As with any medical complication, patients are urged to contact their doctor to get emergency treatment. At the Harman Law Firm, we offer no cost, no obligations consultations to patients or the families of patients who have died to discuss potential lawsuits. Time is of the essence as there may be a time limit to file a claim. Contact our firm today to schedule a consultation.
- The Harman Law Firm represents clients across the country who have been injured by dangerous and defective drugs and medical devices.