Millions of patients suffering from kidney disease rely on dialysis and hemodialysis in order to have toxins removed from their body. Dialysis treatment is critical in keeping patients alive and assisting many who may be awaiting a life-saving kidney transplant. And critically important to this life-saving dialysis process is ensuring that the drug products given to dialysis patients neutralize the acid that builds up in their blood.
Fresenius Medical Care North America manufactures some of these dialysis drug products and is the largest dialysis medical care related company in America. Doctors have trusted Fresenius for years with providing safe and effective drug products for their dialysis patients. Two of the drug products used by nephrologists and manufactured by Fresenius are NaturaLyte and Granuflo.
These products were the subject of a March 2012 FDA Class I recall because of a significantly increased risk of a fatal heart attack to patients undergoing dialysis. It seems that physicians were not made fully aware of the chemical nature of NaturaLyte and Granuflo, causing them to prescribe inaccurate amounts of these drugs.
It was not until March 2012, at the time of the recall, that Fresenius began warning all health care providers of the significance of prescribing accurate units of acids in preparing final buffer solutions.
Incredibly, in November 2011, Fresenius issued an internal memo warning its own clinics of the increased risk of heart problems for patients undergoing dialysis treatment with GranuFlo and NaturaLyte, but failed to warn any doctors who worked outside of its own dialysis treatment centers. According to the memo about 941 patients suffered from cardiac arrests and concluded that patients with elevated levels of bicarbonate had about a six times greater chance of having a heart related episode than those with lower bicarbonate levels. Now, the FDA is apparently investigating whether Fresenius failed to comply with federal regulations by concealing the risks of its products.
If you or a loved one had a heart attack while undergoing dialysis treatment with GranuFlo and NaturaLyte, please contact the attorneys at Kitrick, Lewis & Harris Co., L.P.A. immediately.