GranuFlo and NaturaLyte are medications used to help treat dialysis patients but may in fact be causing them harm. These drugs are designed to help achieve the proper balance of alkaline and acid in a dialysis patient’s blood. GranuFlo is a dry a dry acid powder and NaturaLyte is the more traditional liquid acid. However, these drugs have now been linked to a condition known as metabolic alkalosis, which is a high serum bicarbonate level in the blood. Metabolic alkalosis can cause serious heart problems, cardiac arrest, stroke and death.
GranuFlo and NaturaLyte are manufactured by Fresenisus Medical Care, which is the country’s largest provider of dialysis products and services. Fresenius’ own study linked the use GranuFlo and NaturaLyte with cardiac arrest in 941 dialysis patients. As a result of the study, an internal company memo warned of a "6 to 8 fold greater increase of cardiopulmonary arrest and sudden cardiac death in the dialysis facility" and concluded the problem "need[ed] to be addressed urgently." But instead,the evidence suggests Fresenius covered up the problems with these dialysis drugs. The problems with GranuFlo and NaturaLyte were revealed only when an anonymous source sent the Fresenius internal memo to the New York Times, which in turn started an investigation by the U.S. Food and Drug Administration (FDA).
As a result of its investigation, the Director of Compliance for the FDA criticized Fresenius for failing to notify the public of the problems with the drugs that were clearly identified in the internal memo. The FDA has issued a Class 1 recall of NaturaLyte and GranuFlo, which is the most serious type of recall issued by the FDA. It is reserved only for those situations in which there is a reasonable probability that the product will cause serious negative health consequences or death. Even though GranuFlo and NaturaLyte have been recalled, the FDA continues to investigate the issue of whether Fresenius violated any federal regulations when it failed to disclose the adverse consequences related to its products. Interestingly, Fresenius’ failure to warn its patients has prompted a rebuke from Home Dialyzors United, who in an open letter to Fresenius describing as "unconscionable" the company’s failure to alert medical directors and medical staff of the problems with the drugs and adding that "patients’ lives were at stake and Fresenius did nothing".
Lawsuits are currently being filed against Fresenius and more information regarding the apparent cover-up will surely emerge. But, from the information currently known, it appears that Fresenius was not acting the in the public interest when it ignored its own study and internal memo warning of significant problems with the medications and urging immediate action. If you or a loved one has suffered cardiac arrest, stroke or death following dialysis, GranuFlo or NaturaLyte may be to blame and you should consult with an experienced product liability lawyer. For the past six years, Best Lawyers has recognized John Day in the field of product liability law and named him Personal Injury Lawyer of the Year for Nashville in 2010. If you would like one of our award-winning attorneys to answer your questions and advise you of your rights in a no-cost, no-obligation consultation, call us at 615-742-4880 or toll-free at 866-812-8787 or contact us using this online form.