In March of 2012, the Federal Drug Administration (FDA) issued a statement to all kidney dialysis treatment centers that the use of NaturaLyte should cease. A Class I recall went into effect for this product stating that use could lead to serious side effects or even death.
NaturaLyte is an alkaline-based medication that is used in kidney dialysis machines to help clean the blood of patients receiving this type of treatment. NaturaLyte, a form of bicarbonate, is used in conjunction with GranuFlo to reduce the acid levels in the blood of dialysis patients.
The manufacturer, Fresenius Medical Care (FMC) addressed practitioners on their website, stating that “NaturaLyte’s distinctive proportional blend in each bag, you have made the safest choice for onsite concentrate mixing.” The truth however, was that the mixing was not accurate and most administrators were not informed on how much bicarbonate to prescribe outside of dialysis, causing patients to have extremely high levels of bicarbonate in their blood.
The high levels of bicarbonate in the patient’s bloodstream as a result of this problem caused many patients to suffer from cardiac arrest. In 2010, when this problem began, over 900 people died from a heart attack while receiving dialysis. Additional people suffered from minor hearty attacks and other problems due to this problem outside of the clinic setting.
FMC was aware of this problem, and by November of 2011 issued a memo to all of its clinics to cease use of the product. Clinics outside of their own brand clinics and the patients themselves were not notified of the problem. A whistleblower in March 2012 notified the FDA of the problem and the FDA immediately assigned a Class I recall on the product.
It is believed at this time, the failure to notify dialysis administrators outside of their company and the patients of the potential life threating problems associated with the use of this product was an act of negligence.
If you or a loved one have suffered from any of the side effects associated with this drug during dialysis, you should have your case evaluated by a dangerous medicine attorney. You may be entitled to specific compensation for your injuries.
If your loved one has dies as a result of this medication used during dialysis, it is important to have the medical records reviewed by an attorney. Certain family members may be entitled to receive compensation for their loss.