Dialysis Products Linked to Heart Problems

Dialysis Products Linked to Heart Problems

By Robert J. Boumis

In 2012, the United States Food and Drug Administration issued a class I recall for the dialysis products GranuFlo and NaturaLyte. This is the highest priority level recall that the FDA can issue, reserved for products that pose an immediate, serious risk of loss of life. The FDA only issues this type of recall in the most serious situations.

However, there was a problem. According to a 2011 internal memo from manufacturer Fresenius Medical Care, it was discovered that these dialysis products could be linked with alkalosis. In alkalosis, blood chemistry gets altered in such a way that the pH rises or becomes alkaline relative to normal blood pH.

Most of the chemical reactions in the human body are adapted to function under very specific chemical conditions. Raising blood pH substantially can alter the way ions work in muscle tissue. When the muscle tissue in question is the cardiac muscle, the consequences could translate into life-threatening problems, included cardiac arrest and sudden cardiac death. Using these products was associated with a six-fold increase in the risk of these cardiac problems.

In addition to cardiac arrest, these dialysis products have been linked with a number of other health concern, including stroke, arrhythmia, and dangerously low blood pressure.

In December of 2012, the company issued a statement saying they would stand by their products: “The company’s actions related to these products were appropriate and responsible. Both products are safe and effective and were reviewed and cleared by the Food and Drug Administration several years ago.”

However, this statement is hard to square away with the 2011 memo, indicating awareness of the problems with these dialysis products. Additionally, it is also hard for them to explain why this memo only went to Fresenius-affiliated dialysis centers, not other dialysis centers that used their products.

Despite the FDA’s class I recall of GranuFlo and NaturaLyte, and their own internal memo, Fresenius has pledged to stand by its products through the various lawsuits filed by patients and their relatives. The lawsuits allege that Fresenius knew about these dangerous side effects, and failed to warn patients, physicians, and non-Fresenius dialysis centers about the life-threatened side effects stemming from GranuFlo-induced alkalosis.

If you or someone you know suffered from life-threatening side effects after using GranuFlo or NaturaLyte dialysis products, it can seem like you have few options. However, you can take control of your situation. Start by visiting the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation . Here, you can submit information for review by a lawyer who specializes in this type of drug injury lawsuit. Your information will be reviewed, free of charge, to help you decide what your next steps will be.