Side Effects Of Renal Dialysis Drug Prompts Recall


GranuFlo and NaturaLyte, both drugs from Fresenius Medical, have been recalled following reports of severe side effects that were found to be fatal if not properly administered to patients, medical experts warn. Since the drug has been available, intermediate providers, such as nurses and doctors, were not informed of these potential health risks. A GranuFlo lawsuit has been filed by the victims of those who were once prescribed on the drugs.


Both GranuFlo and NautraLyte are drugs that are openly used for treating chronic renal failure in patients who are on dialysis. When acid builds up in the blood, powdered GranuFlo and its liquid version NaturaLyte are used to negate acid build ups in your blood. Fresenius issued an Urgent Product Notification warning in March 2012 to its customers concerning the dangers of elevated bicarbonate levels being associated with a higher risk of cardiac arrest and possible death when prescribed on these medications.


The FDA has also followed suit in issuing warnings to customers who were prescribed these medications, citing the German pharmaceutical company issuing a Class I recall to be a very serious form of recall. Class I recalls often involve cases in which a product will reasonably cause serious debilitating health effects that may even possibly lead to death. As patients were given these drugs, their chance of suffering a heart attack rose as their bicarbonate levels also increased.


At this time, Fresenius Medical is being investigated for failing to warn customers of the possible health risks of using these drugs before releasing them onto the market. This is in conjunction with the internal memo issued by Fresenius warning their own internal clinics in 2011 of the potential dangers resulting from 941 hemodialysis patients that experienced cardiac arrests in their own facilities compared to 80,000 other patients undergoing the same treatment. That same year, a study was presented to the American Society of Nephrology underscoring the problem of increased bicarbonate levels which resulted in metabolic alkalosis and increased mortality rate.


Evidence has shown that Fresenius Medical may have known about the potential health risks concerning their drugs when they were first approved in 2003, but elected not to inform clinics, patients, or the FDA.


Nephrologists and dialysis nurses were also issued a warning by the FDA on May 25,2012 to always administer these drugs carefully and to take note of the dialysate concentrations, as well as, the levels of these drugs used based on their brand name and their manufacturer’s origin.


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