GranuFlo and NaturaLyte are acid concentrates that are added to dialysate, a fluid used during dialysis. Both are manufactured by Fresenius Medical Care, one of the major providers of dialysis services and medications throughout the United States.
GranuFlo and NaturaLyte are both dangerous medications that could significantly increase the chances of a cardiac event, including a deadly heart attack. The U.S. Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte in 2012.
“This product may cause serious adverse health consequences, including death,” the FDA recall notice stated.
Granuflo and Naturalyte Linked to Metabolic Alkalosis
Dialysis is a procedure that cleanses the body of waste when the kidneys do not work properly and the body cannot cleanse itself. Dialysis patients receive water and medications in a solution called dialysate through a three-stream machine. NaturaLyte and GranuFlo are added to the dialysate in order to neutralize acid buildup in the bodies of dialysis patients.
GranuFlo and NaturaLyte convert to bicarbonates in the body and could result in an excess level of bicarbonates in a dialysis patient’s blood. An excess level of bicarbonates can lead to elevated pH levels called metabolic alkalosis.
Symptoms and complications associated with metabolic alkalosis include:
- Dizziness or light-headedness
- Muscle spasms
- Twitching muscles
- Low oxygen levels (hypoxemia)
- Low blood pressure
- Low potassium levels (hypokalemia)
- Excess carbon dioxide (hypercapnia)
- Cardiac arrhythmia (an irregular heart beat)
- Cardiac arrest
By November 2011, more than 900 people had already experienced sudden cardiac events – including deadly heart attacks – in clinics operated by Fresenius, according to an internal memo obtained by the New York Times. Fresenius sent the internal memo to its company-run dialysis clinics, alerting the clinics to the dangers of NaturaLyte and GranuFlo.
However, Fresenius provides medical products for approximately one third of the 400,000 patients in the United States who require dialysis, and many of these patients are treated at independent clinics that purchase products from Fresenius. No notification of the dangers were sent to other dialysis clinics that used GranuFlo or NaturaLyte, so these other clinics continued to use the medications without being aware of the dangers posed to patients, according to the New York Times.
There were as many as 125,000 patients being treated at these independent clinics and potentially being exposed to an increased risk of metabolic alkalosis.
FDA Class I Recall of Granuflo and Naturalyte
In March 2012, the FDA issued a notice of a Class I recall of GranuFlo and NaturaLyte. “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest,” the FDA recall notice states.
Class I recalls are the “most serious” and are issued “in situations where there is a reasonable probability that use of… [the]… products will cause serious adverse health consequences or death,” according to the FDA.
Fresenius also issued an alert to all clinics two days prior to the FDA recall. The recall and the notice from Fresenius indicated that there was an established link between the use of GranuFlo or NaturaLyte and metabolic alkalosis.
Many dialysis patients were exposed to the dangerous drugs before the recalls were issued.
If you or a loved one was administered NaturaLyte or GranuFlo and experienced a cardiac event or any of the symptoms of metabolic alkalosis, you could be entitled to compensation.
Our South Carolina personal injury attorneys at Joye Law Firm are ready to provide you with a free and confidential consultation to help you determine if you could have a claim. You could be entitled to recover monetary damages for your medical bills, lost wages, pain and suffering, emotional distress, wrongful death, loss of companionship and other losses.
To learn more about how we can help you, call Joye Law Firm at (888) 324-3100 or fill out our online contact form. Our South Carolina drug injury attorneys will treat you with respect and compassion while we work to get you the compensation you deserve.
- FDA List of Recalls
- Fresenius Medical Care – Internal Memo
- New York Times