GranuFlo and NaturaLyte Side Effects
Patients who received dialysis treatment with GranuFlo and NaturaLyte have reported experiencing potentially fatal side effects such as heart attack and stroke. The FDA has issued a Class 1 GranuFlo and NaturaLyte recall based on the severity of these side effects.
Fresenius Medical Care (FMC), the manufacturer of GranuFlo and NaturaLyte, found that patients undergoing dialysis treatments with these products are at a six times greater risk of suffering a heart attack than patients using other dialysis products. Fresenius Medical Care also reported that 941 people had suffered sudden cardiac arrest in their dialysis facilities in 2010 while undergoing dialysis treatment with GranuFlo and NaturaLyte products.
Fresenius Medical Care released this information in an internal memo sent only to physicians working in Fresenius-owned dialysis centers. RenalWEB estimates that 125,000 dialysis patients in non-Fresenius clinics were treated with GranuFlo and NaturaLyte products and not warned of these deadly side effects.
GranuFlo and NaturaLyte side effects occur when the acid concentrates increase bicarbonate levels in the blood to dangerous heights during hemodialysis treatment. Use of GranuFlo and NaturaLyte puts patients with elevated pre-dialysis bicarbonate blood levels at risk for severe side effects including:
- Low blood pressure (hypotension)
- Myocardial infarction
- Heart attack
- Metabolic alkalosis
- Cardiopulmonary arrest
- Sudden Death
If you or a loved one experienced heart attack, stroke or sudden death after receiving hemodialysis treatment with GranuFlo or NaturaLyte acid concentrates, contact the lawyers 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.