The U.S. Food & Drug Administration (FDA) has declared Fresenius Medical Care’s recent warning regarding its GranuFlo and NaturaLyte dialysis products to be a Class I recall, the agency’s most serious category of medical device recalls. In March of this year Fresenius issued a warning to its customers that GranuFlo and NaturaLyte had been associated with elevated bicarbonate levels in patients, a substantial risk factors for cardiac arrest.
The FDA says that such Class I recalls exist when there is a reasonable probability that use of the product will cause serious adverse health consequences or even death. As a result, such warnings are serious and patients who have used such products such paid careful attention to their health.
GranuFlo and NaturaLyte are alkaline substances administered to dialysis patients to neutralize the acid that builds up in their bloodstreams. The products are administered in conjunction with bicarbonate and also contain acetate, an ingredient that is eventually converted into bicarbonate by the body. Fresenius’ products have significantly more acetate than competitor products and thus produce far more bicarbonate in a patient’s body.
According to the New York Times, Fresenius is also being investigated for failing to warn patients about the serious risks associated with its dialysis products. Evidently the company issued an internal memo in November of 2011, warning that 941 hemodialysis patients had experienced cardiac arrest across its more than 600 clinics in 2010 alone. The company then investigated the deaths and discovered that the patients who died had significantly higher bicarbonate levels which increased their risk of heart problems.
While Fresenius took the time to alert its own doctors of the danger, it did nothing to warn the public or the FDA about its findings until the FDA was given an anonymous copy of the memo. The FDA then issued a Class I recall, forcing the company to take steps to advise all the necessary parties about the dangers of its products, not just its own doctors.
If you or a loved one experienced sudden cardiac arrest or sudden heart attack following dialysis with GranuFlo or NaturaLyte, please contact the Georgia product liability litigation attorneys at Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. today to schedule a free consultation.
Source: “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry,” by Andrew Pollack, published at NYTimes.com.