What You Need to Know about the GranuFlo Recall
Fresenius Medical Care issued an Urgent Product Notification for its GranuFlo and NaturaLyte dialysis products in March 2012, after they had been associated with dangerous heart side effects, including fatal heart attacks and cardiac arrest. Months later, the U.S. Food & Drug Administration (FDA) deemed the notification a Class I GranuFlo recall, its most serious type of recall action. If you or someone you care about suffered a heart attack, cardiac arrest or other serious heart problem within 48 hours of a dialysis treatment, you may have been the victim of GranuFlo or NaturaLyte. Here’s what you need to know about Fresenius Medical Care’s GranuFlo recall:
What are GranuFlo and NaturaLyte?
GranuFlo and NaturaLyte are acid concentrates used during dialysis to remove toxins from the blood. GranuFlo is a dry acid, while NaturaLyte is a liquid formulation. Unlike rival products, GranuFlo and NaturaLyte are formulated with sodium diacetate, rather than acetic acid.
Why was the GranuFlo Recall Issued?
The GranuFlo recall was announced after it was found that the drugs had the potential to cause serious complications including heart attacks and arrhythmias. Because of the way they are formulated, GranuFlo and NaturaLyte can potentially raise the body’s bicarbonate levels more than other dialysis concentrates. Unaware of this, some doctors were not adjusting the dosage properly. Excessive bicarbonate levels can lead to a condition called metabolic alkalosis, which has been associated with catastrophic heart events in dialysis patients.
What are Potential GranuFlo Heart Side Effects?
Potential GranuFlo side effects include:
- Low blood pressure
- Hypokalemia (lower-than-normal amount of potassium in the blood)
- Hypoxemia (low blood oxygen)
- Hypercapnia (high concentration of carbon dioxide in the blood)
- Cardiac arrhythmia (abnormal heart rhythm)
- Cardiopulmonary arrest/cardiac arrest
- Heart attack
- Sudden cardiac death
According to an internal Fresenius Medical Care memo circulated in November 2011, 941 patients treated with GranuFlo or NaturaLyte died at Fresenius dialysis clinics in 2010. All of the patients had high levels of bicarbonate in their blood.
When Did Fresenius Medical Care Know of the GranuFlo Heart Risk?
The existence of the November 2011 memo indicates that Fresenius was aware of GranuFlo and NaturaLyte heart risks at that time, months before the GranuFlo recall was announced. However, that memo was only circulated to dialysis clinics operated by Fresenius. The thousands of other dialysis clinics throughout the U.S. that purchased GranuFlo and NaturaLyte from the company were not informed of any issues at that time. In fact, according to a report from The New York Times, it wasn’t until the FDA learned of the November 2011 memo and began asking questions that Fresenius finally notified its customer clinics. The FDA has since launched an investigation to determine if the delayed notification violated the law.
What Legal Recourse do GranuFlo Victims Have?
Already, a number of GranuFlo heart attack lawsuits have been filed on behalf of people allegedly injured by GranuFlo and NaturaLyte. If you or a loved one were injured by GranuFlo or NaturaLyte, you may be entitled to compensation for medical bills, lost wages, pain and suffering and other damages. To learn more about filing a GranuFlo heart attack lawsuit, please call 1-877-779-1414 to speak with an attorney at Bernstein Liebhard LLP today.