GranuFlo has been marketed by FMC as the “most widely-prescribed dry acid product in the dialysis industry,” and is touted as “the safest choice for onsite concentrate mixing,” due to “GranuFlo’s distinctive proportional component blend in each bag.” However, when FMC issued the 2011 internal memo, the company warned that as many as 941 patients had suffered from sudden cardiac arrest due to the improper administration of the dialysis medication. The danger linked to GranuFlo lies in the fact that it allows for a greater conversion of bicarbonates, which are administered to patients during dialysis to neutralize the build-up of acid that occurs during the process. Unfortunately, recent information suggests that elevated bicarbonate levels in kidney failure patients can lead to hemodialysis metabolic alkalosis, a major risk factor for hemodialysis cardiopulmonary arrest, cardiac arrest, heart attack and other potentially fatal side effects.
In medicine, hemodialysis is a process during which toxic waste is removed from the body in patients whose kidneys aren’t functioning properly. During hemodialysis cardiopulmonary arrest, blood stops flowing through one or more chambers of the heart, causing the person to feel a sharp pain or tightening in the chest before losing consciousness. When cardiopulmonary arrest has occurred, there will be no breathing or pulse, and there will also be no heart sounds. The presentation of hemodialysis cardiopulmonary arrest is not subtle. An almost immediate loss of consciousness occurs and the person will fall or slump over, unable to be aroused.
Hemodialysis cardiopulmonary arrest is a medical emergency that can lead to death if the condition is not treated immediately. The proper treatment for hemodialysis cardiopulmonary arrest depends on the severity of the condition and may include medications, angioplasty, or a surgical procedure called coronary bypass grafting. Unfortunately, the prognosis for cardiopulmonary arrest is poor, and the survival rate for victims who receive initial emergency treatment by ambulance is only 2%. For those who do survive this event, complications often involve injury to the brain because, unlike other organs, the brain doesn’t have a reserve of oxygen-rich blood. If the victim’s heart doesn’t return to its normal rhythm quickly, brain damage occurs and death results.
It wasn’t until the FDA received a copy of the FMC internal memo from an anonymous source in May 2012 that the agency warned consumers and healthcare professionals about the risk of serious heart side effects in GranuFlo patients. Because it is the duty of all drug companies to notify the public about all potential drug side effects, FMC is currently under investigation by U.S. drug regulators for failing to warn all patients and doctors about GranuFlo side effects like hemodialysis cardiopulmonary arrest. If you or a loved one have suffered from hemodialysis cardiopulmonary arrest and you believe GranuFlo to be the cause, contact a qualified GranuFlo lawyer to discuss your options for legal recourse. The immediate medical care and long-term treatment required by many hemodialysis cardiopulmonary arrest patients is likely to result in costly medical bills and loss of quality of life. With the help of a skilled GranuFlo attorney, victims of hemodialysis cardiopulmonary arrest and other heart side effects can pursue financial compensation for their injuries, medical bills, and other damages related to the devastating condition.