The FDA has issued a Class 1 Recall of GranuFlo and NaturaLyte, both of which are used in the treatment of acute and chronic renal failure during hemodialysis. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. A recent study conducted by the manufacturer of GranuFlo and NaturaLyte found that the use of these medications during dialysis resulted in a four to six times increased risk of cardiac arrest or cardiopulmonary death.
GranuFlo and NaturaLyte are the same medication, but GranuFlo is a powdered concentrate and NaturaLyte is in liquid form. They contain an ingredient that the body converts to bicarbonate. GranuFlo and NaturaLyte contain more of this ingredient than rival products. Many doctors apparently have not been accounting for this extra bicarbonate contribution from GranuFlo and NaturaLyte when deciding how much bicarbonate to prescribe separately. The result can be, in effect, an overdose of bicarbonate, which can lead to sudden cardiopulmonary death, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.
Both GranuFlo and NaturaLyte are manufactured by Fresenius Medical Care North America. Fresenius is the nation’s largest operator of dialysis centers. Fresenius not only used GranuFlo and NaturaLyte in its dialysis centers but sold these products to other dialysis centers, hospitals, and nephrologists around the country. In November 2011, Fresenius sent an internal memorandum to its centers warning that 941 patients had experienced cardiac arrest (including sudden cardiac death) in 667 of its centers. According to the confidential memo, the data indicated that “the excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients.”
Though Fresenius conveyed to its own centers that the risk to patients was serious and that the issue should be addressed “urgently,” Fresenius did not warn non-Fresenius-owned dialysis centers, nephrologists, the public or the FDA. This meant that patients undergoing dialysis at outside facilities were unnecessarily put at risk, because their dialysis providers were not warned about potential adverse side effects from using GranuFlo or NaturaLyte.
The FDA became aware of the problem only after a copy of the internal memo was anonymously provided to the agency. Non-Fresenius owned facilities were informed when the FDA issued a Safety Communication in May 2012, some six months after the Fresenius-owned facilities. The FDA issued the recall in July 2012 after additional reports of serious adverse events surfaced.
The FDA is investigating the cause of Fresenius’ delay in notifying all physicians, facilities and patients about the increased risk. In an interview with the New York Times, Mr. Steve Silverman, director or compliance for the FDA’s medical device division, said the agency could issue a warning letter to Fresenius if it determined the company should have reported the safety concerns. But even if the company had no legal obligation, he said, “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.” If you need more information on this matter, contact Leigh O’Dell, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Leigh.Odell@beasleyallen.com.
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