GranuFlo & NaturaLyte Lawsuit Lawyer

GranuFlo & NaturaLyte Linked to Heart Attack

The most-widely prescribed dry acid products used in dialysis, GranuFlo & NaturaLyte, have been recalled by the United States Food & Drug Administration (FDA). On March 29, 2012, the FDA issued a Class I Recall, which is the most severe sanction the FDA can impose. This sanction is reserved for products that cause “serious adverse health consequences or death.” The FDA issued the recall after learning of the severe cardiac risks associated with GranuFlo and NaturaLyte.

In its most recent notice to physicians, the FDA warned that NaturaLyte and GranuFlo cause metabolic alkalosis. Metabolic alkalosis leads to low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. If not appropriately treated, this may lead to cardiac arrest and death. Our Houston personal injury lawyers at Fleming | Nolen | Jez, L.L.P. can represent you if you have been injured by a dangerous pharmaceutical drug such as GranuFlo or NaturaLyte.

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Here are some facts you should know about GranuFlo and NaturaLyte:

  • 500,000 Americans require dialysis to treat kidney disease.
  • There are over 5,700 dialysis centers in the United States.
  • 3,300 dialysis clinics use GranuFlo & NaturaLyte.
  • 260,000 dialysis patients have been prescribed GranuFlo & NaturaLyte.
  • 125,000 of those dialysis patients have been prescribed GranuFlo & NaturaLyte in non-Fresenius dialysis clinics.
  • 4,655 dialysis patients suffered possible GranuFlo-related cardiac arrests between January 1 and December 31, 2010.
  • 194 dialysis patients suffered possible GranuFlo-related cardiac arrests in a non-Fresenius clinic each month they went unwarned.

Fresenius Medical Care Failed to Tell Doctors About the Risks

Fresenius Medical Care manufactures GranuFlo and NaturaLyte, which have been prescribed to over 200,000 dialysis patients. Fresenius is also the leading supplier of dialysis machines and other products used in dialysis clinics across the United States. For months, Fresenius knew that GranuFlo & NaturaLyte were associated with an increased risk of cardiac arrest and heart attack. However, the medical company did not inform the FDA, dialysis centers, or physicians about the known cardiac risks.

Internal data from Fresenius showed a four to six-fold increase in cardiac arrests and heart attacks following dialysis. The FDA was concerned that Fresenius did not take steps to inform dialysis centers and physicians that GranuFlo & NaturaLyte contributed to a sharp rise in deaths associated with sudden cardiac arrest following dialysis. Top executives at Fresenius claim that they had no way of warning other dialysis clinic and physicians.

If you or a loved one experienced cardiac arrest or heart attack following dialysis with GranuFlo or NaturaLyte, contact Fleming | Nolen | Jez, L.L.P. at (866) 977-6671.