GranuFlo and NaturaLyte
GranuFlo and NaturaLyte are medications used on dialysis patients undergoing treatment for kidney disease and renal failure during dialysis treatments. Manufactured by Fresenius Medical Care (FMC), a German company that provides medical supplies and services, GranuFlo was approved by the United States Food and Drug Administration (FDA) in 2003. Since its approval, GranuFlo has become the most commonly prescribed dialysis treatment drug available. Approximately 400,000 Americans receive dialysis treatments multiple times a week. GranuFlo and NaturaLyte is used on nearly half of those patients.
What Does GranuFlo Do?
During dialysis, the powdered GranuFlo or its liquid equivalent NaturaLyte are administered to the patient as part of the blood filtration process. These drugs are part of the dialysate solution and are composed primarily of an acetate and sodium diacetate. Their function is to neutralize excess acid present in the patient’s blood due to the kidneys no longer filtering properly. The standard dialysate solution contains bicarbonate, filtered water and an acid concentrate (GranuFlo or NaturaLyte). The amounts of bicarbonate and drug concentration are adjustable depending on how it is ordered by the doctor.
When the acetate is introduced to the body from dialysis it is converted by the liver into additional bicarbonate. This means that patients receiving the sodium diacetate found in GranuFlo and NaturaLyte are receiving nearly twice the amount of bicarbonate as compared to other drugs used in dialysis. The build up of excess bicarbonate can cause a variety of complications ranging from mild to fatal. It was discovered that patients with high bicarbonate levels having been given incorrect doses of were 6 – 8 times more likely to suffer from cardiac arrest.
Side effects of GranuFlo and NaturaLyte include:
- Low blood pressure
- Low blood oxygen levels
- Low potassium
- High carbon dioxide
- Irregular heart beat
- Congestive heart failure
- Cardiac arrest
Shortly after the FDA recall a large number of lawsuits have been filed against Fresenius by people who suffered heart attacks and other complications and by people who lost loved ones after being treated with GranuFlo and NaturaLyte. All federally filed lawsuits were consolidated to the U.S. Federal Court for the District of Massachusetts in March 2013. As of February 2014 there were 515 lawsuits pending against Fresenius. As of January 2015 there were 2,655 lawsuits from 26 states.
The lawsuits allege that FMC:
- Knew or should have known about the increased risk of death and serious injury.
- Knew that use presents an increased risk of serious or fatal cardiovascular injury.
- The risk was misrepresented and concealed by FMC.
- Advertised as safe even though FMC knew or had reason to know it was not.
- Failed to adequately warn doctors and professionals about the risks.
- Failed in their responsibility to instruct/train/inform professional involved in dialysis treatment to ensure proper use in a safe, effective manner.
- Failed to properly warn patients about risks specifically for cardiac arrest.
- Labeling, packaging and instructions failed to provide adequate instructions and warnings regarding use and company failed to include warnings with full knowledge of risk.
In February 2016 Fresenius announced that a they reached an Agreement In Principle with a committee designated by Plaintiffs to resolve litigation in the U.S. involving GranuFlo and NaturaLyte. Under that Agreement the settlement would be 250 million, provided that 97% of the plaintiffs agree to the settlement by July 2016. Fresenius posted an article on their website stating, “Insurers will fund the settlement amount with $220 million. “The company expects a pre-tax charge of $60 million from the settlement and other costs to finalize this matter.”
GranuFlo and NaturaLyte are still manufactured and in use, continuing to be a leading product in the dialysis market. There has been no change in the composition. Fresenius still claims both products are safe and effective when used as prescribed and directed. Dr. Daniel Coyne, Director of Hemodialysis at Washington University in St. Louis reported after an initial round of testing 30% of their patients had bicarbonate levels that were too high. Dialysis clinics across the country have adopted the additional practice of regularly checking patients bicarbonate levels and adjusting doses if necessary.