GranuFlo & Dialysis History

Kidneys provide an important role to the body. Essentially, the organs work to clean the body’s blood supply of toxins, like acids. However, when the kidneys no longer function properly, or fail to work at all, as is the case during kidney disease, patients opt for treatment in the form of dialysis.

Hemodialysis has its roots in the 1960s, when doctors would hook patients up to a special blood filtering machine, slowly removing the toxins from the blood before pumping the clean blood back into the body. Over the years, medical companies began producing dialysis machines and medications to aid in the process.

Soon, Fresenius Medical Care, a medical company out of Germany, became the leader in treating kidney disease. The company also manufactures dialysis machines and disposable products, and in 2003, the U.S. Food and Drug Administration gave the nod to Fresenius to sell GranuFlo Dry Acid Concentrate, as well as its liquid counterpart NaturaLyte, for use in dialysis treatments.

The drugs, according to the FDA, were to be used with a three-stream hemodialyis machine, which is specifically calibrated to monitor a patient’s acid and bicarbonate levels. This is because GranuFlo and NaturaLyte contain higher-than-normal levels of bicarbonate, which helps keep the blood from getting too acidic.

Over time, however, researchers began connecting the drugs to a spike in heart complications during and after dialysis treatments. As research suggests, dialysis doctors have often prescribed additional medications that would introduce bicarbonates to their patients. When paired with GranuFlo and NaturaLyte, overdoses are likely. Too much bicarbonate can result in various heart complications, like low blood pressure and cardiac arrhythmia, which can lead to sudden heart attacks and death.

According to the GranuFlo Dialysis Information Center, Fresenius Medical Care sent a letter in November of 2011 to all the company’s clinics and doctors stressing the importance of monitoring bicarbonate levels in each patient. The letter referenced the reported 941 deaths that occurred through its centers the previous year as a result of sudden cardiac arrest during or following dialysis treatments. Although circulated through the company, the letter never reached an estimated 125,000 patients undergoing GranuFlo treatment at non-company clinics. It wasn’t until March of 2012 that Fresenius notified all its clients about the risks.

On March 29, 2012, The FDA issued a recall on GranuFlo and NaturaLyte. The recall, deemed a Class 1 offense, labeled the medicine as having a high probability of causing adverse side effects or death.

If you or a loved one have experienced heart conditions following the use of GranuFlo while undergoing dialysis, contact our team of lawyers to help assert your legal rights.