The kidneys are vital in the blood filtering and cleaning process. For the 0.2% of the U.S. population that do not have fully functional kidneys, the process of hemodialysis is necessary. Hemodialysis uses machines that take out the patient’s blood, cleans it, and returns it to the body. Dialysates are the chemicals used during dialysis to clean the blood by neutralizing the buildup of acid. The two most widely used dialysis provider, Fresenius Medical Care, uses its own proprietary dialysates, GranuFlo and NaturaLyte, and also sells them to other dialysis centers. GranuFlo and NaturaLyte both contain sodium diacetate, which no other dialysates contain. The two parts of sodium diacetate, acetate and bicarbonate, work by neutralizing the excess acid, but the acetate gets converted into bicarbonate. Excess bicarbonate, along with the bicarbonate in the sodium diacetate, creates problems for the patient such as sudden heart attacks and strokes. And because GranuFlo and NaturaLyte users receive twice the bicarbonate as patients that use other dialysates, their risk of heart attack and strokes is increased by 600%, according to Drug Watch.
Half a Million People Have Taken GranuFlo Since its 2003 Release
Since its release in 2003, two million people took GranuFlo in Fresenius Medical Care dialysis centers and other dialysis centers that used GranuFlo. This means that hundreds of thousands of people were at risk of sudden and fatal heart attacks and strokes began occurring. Back in 2010, Fresenius found out, through their own internal investigation, that GranuFlo was causing heart attacks. In fact, 941 people who used GranuFlo or NaturaLyte had heart attacks in 2010, according to the New York Times. But it was not until 2011 that Fresenius sent internal memos only to its own clinics of their previous year’s findings that their products caused heart attacks, strokes, and other medical complications. Fresenius did not send any warnings to other physicians or dialysis clinics that they sold their products to.
GranuFlo and NaturaLyte Got Class I Recalls From the FDA
The U.S. Food and Drug Administration (FDA) finally recalled GranuFlo and NaturaLyte in 2012 with a class I recall, which is their most serious type of recall only used when the product puts users at risk of death. Many victims and the survivors of the deceased began filing lawsuits on the grounds that Fresenius knowingly sold a dangerous product and failed to warn doctors and patients.
Other Health Problems Caused by GranuFlo and NaturaLyte
In addition to heart attacks and strokes, GranuFlo and NaturaLyte also create the following health problems:
- Irregular heartbeat;
- Low blood pressure;
- High blood C02;
- Low blood oxygen; and
- Low potassium.
Low potassium causes the a long list of problems including muscle tingling, muscle spasms, muscle damage and weakness, constipation, fatigue, and numbness.
If you or someone you love, or a deceased family member, took GranuFlo or NaturaLyte and suffered any of the above mentioned health complications, you may be entitled to compensation. Contact an experienced faulty drug attorney today for legal council.
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