GranuFlo and NaturaLyte

GranuFlo and NaturaLyte Recall Lawyers

In June of 2012 the Food and Drug Administration (FDA) began investigating whether the German company Fresenius Medical Care had failed to warn clinics that its dialysis treatment, called GranuFlo, might cause heart attacks if it is not properly dosed.

What Is GranuFlo?

Fresenius Medical Care’s dialysis product GranuFlo is a “dialysate,” i.e., a substance that physicians can use to treat acute and chronic renal (kidney) failure.

The kidneys clean the blood of waste chemicals and help maintain the body’s pH level. When they fail, the body’s pH levels become more acidic than they should be. Dialysates used to treat kidney failure include chemicals that the body can convert into the alkaline substance bicarbonate, which neutralizes some of the acid buildup in the blood stream.

GranuFlo Might Cause Heart Attack Side Effects

GranuFlo contains more bicarbonate than other dialysates, and a June 2012 New York Times article describes Fresenius’s knowledge of the risks posed by its product’s high bicarbonate level.

According to the article, Fresenius sent a memo to its clinics warning that the higher bicarbonate levels in GranuFlo had caused 941 heart attacks in the company’s own clinics in 2010, leading the company’s researchers to estimate that GranuFlo increases a patient’s risk of heart attack by six times. Fresenius did not send the memo to GranuFlo-using clinics that the company didn’t own, however, and the FDA consequently began investigating Fresenius for possible violations of federal regulations, the Times reports.

In late May 2012 the FDA issued a medical device safety communication advising doctors and other health care professionals to monitor their dialysis patients closely since dialysates can contain more alkaline chemicals (acetate, acetic acid, and citrates) than they might expect.

The result of excessive alkalines in the bloodstream can lead to metabolic alkalosis, a dangerous condition that can cause the following symptoms and side effects:
  • Low blood pressure;
  • Hypokalemia – low potassium in the blood, which the heart and other muscles require to function properly;
  • Hypoxemia – low levels of oxygen in the blood;
  • Hypercapnia – excessive carbon dioxide in the blood;
  • Cardiac arrhythmia – irregular heartbeat; and
  • Cardiopulmonary arrest.

Contact our GranuFlo and NaturaLyte Attorneys

If you or a person you love has suffered injury or death after dialysis, you may be a victim of defective pharmaceuticals GranuFlo or NaturaLyte, made by Fresenius Medical Care.