Side Effects of Granuflo and NaturaLyte Dialysis
NaturaLyte and Granuflo are products manufactured by Fresenius Medical Care that are used during hemodialysis treatments at clinics throughout the United States. A NaturaLyte and Granuflo recall was issued in 2012, amid concerns about serious and potentially life-threatening health risks.
As a result of problems with the warnings and instructions provided by the manufacturer, side effects of Granuflo and NaturaLyte dialysis treatments may have caused users to face an increased risk of a heart attack, stroke, cardiopulmonary arrest or sudden death.
The dialysis treatment lawyers at Saiontz & Kirk, P.A. are reviewing whether individuals may be entitled to financial compensation through a NaturaLyte lawsuit or Granuflo lawsuit for serious or catastrophic injuries that occurred during or with 48 hours of dialysis treatment.
Request a free consultation and claim evaluation to review the circumstances surrounding a lawsuit over Granuflo or NaturaLyte dialysis products.
NATURALYTE AND GRANUFLO SIDE EFFECTS
Dialysis treatment involves the use of a dialysate solution prescribed by physicians, which is used in combination with the dialysis machine and dialyzer to remove waste from the blood for individuals with kidney problems.
Granuflo is a dry acid concentrate and NaturaLyte is a liquid concentrate. These products contain sodium acetate, which converts to bicarbonate. The products contain more acetate than rival products, with Granuflo containing 8.0 mEq/L of acetate and NaturaLyte Liquid containing 4.0 mEq/L.
As as result of improper warnings and instructions provided by the manufacturer, these dialysis treatments may increase bicarbonate levels beyond what was initially intended and prescribed by the doctor.
Bicarbonate is an alkaline substances, which is known to substantially increase the risk of:
- Heart Attack
- Cardiopulmonary Arrest
- Low Blood Pressure
- Sudden Cardia Death
Although Fresenius Medical Care knew or should have known about the risk of NaturaLyte or Granuflo problems, they ignored the potential risks and continued to actively promote the products, attempting to convert clinics to the use of Granuflo and bundled the product with other dialysis products to provide pricing discounts.
NATURALYTE AND GRANUFLO RECALL AND WARNINGS
Granuflow was introduced in 2003. Amid aggressive markting and promotion, it was being used during hemodialysis treatment for the majority of all patients in the United States by 2012, when information was finally discovered that it may be causing hundreds of heart attacks and deaths a year.
Between 2004 and 2011, Fresenius Medical Care noted an increase in serum pre-dialysis bicarbonate levels. Since NaturaLyte and Granuflo convert to bicarbonate, these higher pre-dialysis levels pose a substantial risk of problems, and the manufacturer recklessly delayed providing adequate warnings or instructions about the importance of monitoring bicarbonate levels and adjusting buffer prescriptions.
In November 2011, Fresenius Medical Care sent an internal memo to physicians in dialysis clinics owned by the company, warning about the risk of NaturalLyte and Granuflo problems (PDF). However, this information was only provided to Fresenius dialysis clinics, not to hundreds of other doctors throughout the U.S. who used the products.
After noting that 941 individuals suffered a cardiac arrest during dialysis treatment at a Fresenius clinic in 2010, the company warned their doctors to carefully monitor and adjust dialysate bicarbonate prescriptions monthly and to provide immediate attention to patients with serum pre-dialysis bicarbonate levels of greater than 24 mEq/L. Similar warnings and information was withheld from other clinics that purchased and used NaturaLyte or Granuflo dialysis treatments, placing patients at a substantial risk.
After an anonymous source provided this letter to the FDA, the regulatory agency sent an inquiry to Fresenius, which prompted the company to finally provide information to other clinics in March 2012 (PDF).
The FDA has classified this action as a Granuflo recall and NaturaLyte recall, impacting products manufactured and distributed between January 2008 and June 2012. Although dialysis clinics were not directed to immediately stop using the products or to return them, Granuflo and NaturaLyte were recalled for re-labeling and updated operating manuals were provided for dialysis machines.
NATURALYTE AND GRANUFLO LAWYERS
The NaturaLyte and Granuflo lawyers at Saiontz & Kirk, P.A. are reviewing potential claims on behalf of individuals who have experienced problems during dialysis treatment or within 48 hours after hemodialysis that may have involved Fresenius products.
Free consultations and claim evaluations are provided to help families determine if financial compensation may be available through a NaturaLyte or Granuflo dialysis wrongful death lawsuit or an individual injury claim.
All cases are reviewed by our product liability lawyers on a contingency fee basis, which means that there are no out-of-pocket expenses to hire our law firm and you pay no attorneys fees unless a recovery is obtained.