Granulose and NaturaLyte and Cardiac Health Risks
The FDA announced a Class 1 recall of dialysis products, GranuFlo and NaturaLyte in June of 2012 because these products may potentially increase the likelihood of cardiac arrest in some patients. The concentrated forms of GranuFlo and NaturaLyte, made by Fresenius Medical Care Company, contain an ingredient that the body converts to bicarbonate. High levels of bicarbonates are linked to increased rates of cardiac health problems.
When patients undergo dialysis, they use a dialysate solution that cleans the blood of waste chemicals as the blood flows through the artificial kidney. GranuFlo and NaturaLyte differ from other dialysate solutions in that these products contain sodium diacetate as opposed to similarly marketed products that contain acetic acids. The human body converts sodium diacetate to bicarbonate at nearly two times the rate of acetic acids. These increased levels of bicarbonates significantly increase the risk of a heart attack in patients.
Fresenius Internal Memo Warning
In November of 2011 Fresenius Medical Care Company (FMC) issued an internal memo warning that the use of GranuFlo pointed to higher levels of bicarbonates in treating patients, increasing the risk of heart attack by six times that of competing dialysis products. FMC reported this problem to clinics owned under the Fesenius name but did not send the memo – or any other warning – to clinics using GranuFlo that were NOT owned by FMC. The internal memo was eventually leaked to the United States FDA in 2012 leading to an immediate Class 1 Recall of GranuFlo and NaturaLyte. The FDA warned of serious heart-related risks stemming from these FMC products such as:
- Sudden cardiac arrest
- Sudden heart attack
- Hemodialysis cardiac arrest
- Hemodialysis cardiopulmonary arrest
- Low blood pressure
- Low potassium levels in blood
A number of lawsuits are arising as a result of the GranuFlo and NaturaLyte recalls resulting from the fact that Fresenius Medical Care (FMC) had evidence and indications that its products increased the risks of serious and sometimes deadly cardiovascular injury but FMC failed to warn doctors, dialysis clinic personnel and patients of these risks.
Legal Help for GranuFlo and NaturaLyte Patients
Oftentimes patients are unaware of the brand names of the dialysis concentrate product used by their hemodialysis centers and clinics. A number of dialysis centers used GranuFlo and NaturaLyte for dialysis without the knowledge of the increased risks of cardiovascular problems. If you or a loved one has suffered heart problems while undergoing dialysis in Kentucky, you may want to contact an attorney. A lawyer will help you to discover if GranFlo or NaturaLyte products made by Fresenius Medical Care may have contributed towards cardiac health issues. Feel free to contact the Kentucky law practice of Brett H. Oppenheimer, PLLC at (502) 242-8877, or fill out our contact form for a free consultation. Brett’s office is in Louisville, but he handles cases across Kentucky in the areas of Product Liability, Personal Injury and Medical Malpractice.