FDA INVESTIGATING FRESENIUS OVER KIDNEY DIALYSIS HEART ATTACK RISKS

The United States Food and Drug Administration is investigating Fresenius Health Care, one of the world’s largest kidney dialysis providers, for Failing to inform customers that a product used in the dialysis machines may drastically increase the risk of heart attacks if not used properly. A wesite,RenalWEB,published an internal memo last month issued by Fresenius in November warning doctors at the company’s dialysis centers of a large spike in patients who died abruptly from cardiac arrest from improper use of GranuFlo product as part of the procedure. GranuFlo contains an ingredient which the body turns to bicarbonate which helps neutralize the acid building up in the blood when kidneys don’t work. According to the November 4 memo, 941 patients treated in Fresenius health clinics suffered cardiac arrest in 2010. While the company notified its doctors about the issue, it did not inform other non-company centers using the product to treat thousands of other patients.