DANGEROUS DRUGS / GranuFlo and NaturaLyte Recall

GranuFlo and NaturaLyte Recall

GranuFlo and NaturaLyte, two substances manufactured by Fresenius Medical Care and used in dialysis at dialysis centers worldwide, have been linked to serious cardiac events including sudden cardiac death.

Fresenius Medical Care (FMC), a German-based medical product and service provider, is the leading supplier of dialysis machines and disposable products for patients undergoing dialysis in North America.  With a network of over 2,100 facilities in North America, they are also the continent’s largest operator of dialysis centers.  Two FMC products, GranuFlo and NaturaLyte, were issued a class 1 recall on March 29, 2012 due to these products being linked with adverse side effects including:

  • Sudden Cardiac Death
  • Cardiopulmonary Arrest
  • Heart Problems
  • Metabolic Alkalosis
  • Low Blood Pressure
  • Stroke

Dialysis is a process that performs the function of the kidney in clearing toxic wastes from the blood.  Part of this process is providing the alkaline substance bicarbonate in order to neutralize acid built up in the blood over time.  GranuFlo and NaturaLyte contain an ingredient that the body converts to bicarbonate.  FMC’s products contain greater amounts of this ingredient than competing products, leading doctors using these products to miscalculate when prescribing bicarbonate separately.  The result of this is an excess of bicarbonate in the blood, which recent studies suggest can lead to serious health problems.

In November, 2011 FMC sent out an internal memo stating concerns about the improper use of their products.  This memo stated that 941 dialysis patients in Fresenius operated clinics suffered sudden cardiac arrest in 2010, and that patients with high levels of bicarbonate in the blood were six times more likely to suffer heart problems than other patients.  Though FMC notified their own facilities of this risk, they failed to notify the many facilities around the world also using their products.  These other facilities were not notified until late March, after a copy of the internal memo was leaked to the FDA.

Read More:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305477.htm

http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=0

http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf

http://www.renalweb.com/writings/alkalosis/FMC_MemoToOutsideGranufloCustomersMarch-29-2012.pdf

The lawyers at Gancedo Law Firm and the Granuflo Legal Alliance are investigating cases involving suspected injuries resulting from the use of GranuFlo and NaturaLyte at dialysis centers.  If you or a loved one suffered a heart event following dialysis, you may be entitled to compensation.  Call us toll-free at (800) 500-5735 to receive a free consultation with one of our GranuFlo / NaturaLyte lawyers, or complete our quick intake form on the right to receive a free case evaluation.