GranuFlo and NaturaLyte Side Effects

The Food and Drug Administration (FDA) has issued a Class 1 recall of GranuFlo and NaturaLyte based on evidence that the dialysis products can cause potentially fatal side effects such as heart attack and stroke when used during hemodialysis treatment.

GranuFlo acid concentrate powder and NaturaLyte liquid acid concentrate contain sodium diacetate, which can result in bicarbonate overdoses for dialysis patients that already have elevated bicarbonate levels before beginning treatment. High bicarbonate blood levels can lead to severe side effects such as heart attack, stroke, and sudden death.

Fresenius Medical Care (FMC), manufacturers of GranuFlo and NaturaLyte, found that patients undergoing dialysis treatments with their products are at a six times greater risk of suffering a heart attack or sudden cardiac death than patients using other dialysis products.

Fresenius also reported that 941 hemodialysis patients had suffered sudden cardiac arrest in their clinics while undergoing dialysis treatment with GranuFlo and NaturaLyte products. This information was released in a November 2011 internal memo sent only to dialysis centers owned by FMC. The FDA issued the Class 1 recall after receiving a leaked copy of the Fresenius memo in March 2012. GranuFlo and NaturaLyte concentrates were manufactured and distributed from January 2008 through June 2012.

Use of GranuFlo and NaturaLyte during hemodialysis treatment places patients at risk for a range of severe side effects, including:

  • Stroke
  • Low blood pressure (hypotension)
  • Myocardial infarction
  • Heart attack
  • Cardiopulmonary arrest
  • Death

If you or a loved one experienced side effects such as heart attack or strokeĀ from hemodialysis treatment with GranuFlo or NaturaLyte, contact the dialysis injury attorneys at Hissey Kientz, LLP for a free case evaluation. You can reach us by calling toll-free at 1-866-275-4454, or by filling out our free contact form on the right of this page.

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