FDA Raises Concerns about GranuFlo, NaturaLyte Used in Dialysis
Missouri residents with damaged or failing kidneys frequently go through dialysis. The dialysis process uses a machine to do what the kidneys do in healthy patients: clean the blood and restore electrolyte balance. A compound called a “dialysate” is a key part of the process - but when a dialysate is not manufactured safely, serious injuries can result.
The U.S. Food and Drug Administration (FDA) has issued several warnings about two particular brands of dialysate, GranuFlo and NaturaLyte. Both are manufactured by Fresenius Medical Centers, the country’s largest dialysis provider, and both are used in Fresenius dialysis centers, as well as by other dialysis providers.
Concerns about GranuFlo and NaturaLyte center around the creation of compounds called bicarbonates. Bicarbonates are frequently prescribed to kidney patients in order to neutralize excess acid in the bloodstream. However, GranuFlo and NaturaLyte, when used, also cause a buildup of bicarbonates in the blood - a risk that many other brands of dialysate have not posed, according to the FDA.
If a patient is exposed to too much bicarbonate at once, he or she may suffer a serious or even fatal heart attack. Other serious medical conditions, like dangerously low levels of oxygen in the blood (hypoxia) or dangerously low blood pressure, can also result from excessive bicarbonates in the bloodstream. These conditions increase the risk of and may even trigger a heart attack.
If you’ve been injured during dialysis, determined Missouri GranuFlo injury lawyer John Page can help. Contact us today to learn more.