GranuFlo and NaturaLyte are used during dialysis to reduce the amount of acid in the blood. In March 2012, Fresenius issued an “Urgent Product Notification” to its customer clinics warning of possible heart risks associated with the products. According to the notice, both have the potential to cause a rapid and unsafe elevation of bicarbonate, which creates a substantially increased risk of cardiopulmonary arrest and death. The U.S. Food & Drug Administration (FDA) would later deem Fresenius’ notification a Class I recall, its most urgent type of recall.*
According to a report in The New York Times, Fresenius Medical Care is already the subject of a U.S. Food & Drug Administration (FDA) investigation stemming from the company’s handling of the GranuFlo and NaturaLyte recall announced earlier this year. The agency is trying to determine if Fresenius Medical Care’s failure to warn its customers about serious heart side effects associated with the improper dosing of GranuFlo and NaturaLyte may have violated federal law.*
“Prior to the GranuFlo recall, both drugs were used by thousands of dialysis clinics throughout the U.S. Tens of thousands of patients may have been placed in danger by Fresenius’ actions,” says Attorney Tom Carse, who’s Dallas law firm represents victims of defective drugs and medical devices. The firm is currently offering free lawsuit evaluations to dialysis patients allegedly injured by GranuFlo or NaturaLyte.
GranuFlo and NaturaLyte are acid concentrates used during dialysis to reduce the amount of acid in the blood. On March 29, 2012, Fresenius Medical Care issued an Urgent Product Notification to its customer clinics warning of possible heart risks associated with GranuFlo and NaturaLyte. Compared to rival products, GranuFlo and NaturaLyte contain higher levels of an ingredient that the body converts to bicarbonate. If a doctor fails to account for this when prescribing the dosage for the drugs, patients may experience a condition called alkalosis, which has been associated with cardiovascular death and catastrophic heart injuries in patients undergoing dialysis treatment. This notification would later be deemed a Class I recall by the U.S. Food & Drug Administration (FDA).
According to The New York Times, Fresenius had issued a similar warning to dialysis clinics it owned months earlier, in November 2011. The document reported that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. Fresenius’ own medical staff had determined that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels, according to the document. Yet while the internal memo characterized the problem as one that “needs to be addressed urgently,” Fresenius did not send a similar warning to the thousands of customer clinics it supplied with GranuFlo and NaturaLyte at that time. The March 2012 warning to customers was issued only after the FDA learned of the November 2011 memo and began questioning Fresenius about it, the Times said.