For any of the over 400,000 Americans currently undergoing periodic dialysis treatment for their kidney failure, the recent GranuFlo recall has been startling and unsettling news. One of the most widely used drugs for treatment of renal (kidney) failure, it is a dry acid compound in concentrate form, used in dialysis. A drug injury lawyer will protect your rights and ensure that you receive all the help you are legally entitled to while you or a loved one is undergoing
Dialysis is the practice of removing toxic waste from the blood stream—the manual process of carrying out the function of the human kidney. In order for this to be done, a solution called dialysate is required. This three part mixture is comprised of sterilized water, and concentrates of bicarbonate and acid. GranuFlo contains acetic acid and sodium acetate, which a patient’s body subsequently converts into bicarbonate.
However, the drug contains more bicarbonate than other comparable drugs on the market, and this has caused some health care professionals to incidentally overuse it. This has led to overdose and fatal injury in a number of case studies, and was the impetus for the recall and a growing number of GranuFlo lawsuits.
According to representatives of the company Fresenius who produces the drug, it is not inherently dangerous. Moreover, Fresenius officials believe human error while mixing the dialysate solution is the reason for the deaths and the resulting GranuFlo recall.   Those taking the medication while receiving dialysis treatment have met some terrible fates—facing severe damage to the heart. Strokes, heart attacks, myocardial infarction, hypotension, and cardiac arrest have all been reported upon taking the drug.
In March of 2012, the United States Food & Drug Administration issued a GranuFlo recall, and deemed it “Class 1”—putting it in the most serious category of recalls which involve the chance of death. Resulting from the lack of necessary warning labels and proper instructions from the drug manufacturer, dialysis treatment centers were inadvertently giving their patients too high of bicarbonate levels. It is known that the company knew of the potential danger, and dubiously continued promoting their product anyway.
This finding from the FDA came following a bit of a faux pas on the part of Fresenius Medical Care, the producer of the drug. Fresenius owns and operates many dialysis clinics nation-wide, and sells their drugs to yet many other dialysis clinics. In the year 2010, Fresenius discovered that nearly a thousand patients suffered from cardiac arrest during or immediately following dialysis treatment in their own clinics. Rather than coming forward with the information to the public, a private internal memo was sent to all clinics operated by the company—stating the danger of the drug. This information was not immediately given to the many other dialysis clinics throughout the country that also used the drug. This memo was later leaked and made public—illustrating the extreme negligence on behalf of the drug company, prompting the GranuFlo recall.
Patients have the right to know the “supposedly” approved medication they are taking is safe and isn’t life threatening. If facing severe health problems due to this drug, or the loss of a loved one due to its effects—it is important to consider consulting with a drug injury attorney and seeking justice. Anyone unfairly subjected to potentially deadly risks is likely eligible to be compensated.