The Food and Drug Administration (FDA) has issued a recall of Granuflo® and NaturaLyte® based on evidence that these dialysis products may cause serious side effects such as heart attack, stroke, and sudden death. The March 2012 recall occurred after the FDA was presented with a leaked internal memo from Granuflo® and NaturaLyte® manufacturer Fresenius Medical Care (FMC).
Granuflo® and NaturaLyte® are acid concentrates that become components of dialysate, which is used during hemodialysis treatment to neutralize acid build up in the blood. Granuflo® is a dry acid and NaturaLyte® is a liquid dialysate formulation.
In November 2011, Fresenius Medical Care sent an internal memo to physicians working in dialysis centers owned by FMC that warned of potentially fatal side effects associated with elevated bicarbonate levels in the blood caused by Granuflo® and NaturaLyte® products. Granuflo® and NaturaLyte® side effects include heart attack, low blood pressure, myocardial infarction, stroke, metabolic alkalosis, and cardiopulmonary arrest.
In the memo, Fresenius reported that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after receiving dialysis treatment with Granuflo® and NaturaLyte®. Fresenius studies also 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. The manufacturer failed to offer the same warning to thousands of physicians and clinics not owned by Fresenius Medical Care.
Granuflo® and NaturaLyte® Attorney in Las Vegas
If you or a loved one has been injured as a result of using either one of these products, you may be entitled to compensation. The Richard Harris Personal Injury Law Firm in Las Vegas, Nevada can help you with your case. We have experienced attorneys on staff to evaluate your case for you. Don’t hesitate, contact us today.
This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration
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