GranuFlo and Naturalyte were recalled in March 2012. These products contained an ingredient that the human body converts into bicarbonate, and doctors had not been accounting for this extra bicarbonate contribution when deciding how much bicarbonate to prescribe separately. The result can be, in effect, an overdose of bicarbonate, which some recent studies have suggested could lead to heart problems.
Overdoses of bicarbonate from GranuFlo and NaturaLyte can reportedly cause these side effects and complications:
- Heart attack
- Low blood pressure
- Low potassium in the blood
- Low levels of oxygen in the blood
- Excessive carbon dioxide in the blood
- Cardiac arrhythmia (irregular heartbeat)
The U.S. Food and Drug Administration (FDA) categorized the GranuFlo recall and the NaturaLyte recall as a “Class I recall.” The agency reserves that designation for the “most serious type of recall and for instances that involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the FDA’s web site.
Indeed, GranuFlo and NaturaLyte had been used for almost 20 years before, in Nov. 2011, the manufacturer Fresenius sent an internal memo to the doctors in Fresenius’s own clinics warning them that the higher bicarbonate levels in GranuFlo had caused 941 heart attacks in the company’s own clinics in 2010, leading the company’s researchers to estimate that GranuFlo increases a patient’s risk of heart attack by six times. Even then, Fresenius did not send the memo to GranuFlo-using clinics that the company didn’t own. Only in late March 2012, after the FDA had anonymously received a copy of the internal memo that Fresenius had sent to its own dialysis clinics, did Fresenius warn other dialysis clinics about the heart attack risks GranuFlo and NaturLyte pose.
Many harmed patients and their families have banded together to take action against Fresenius. The attorneys at Swartz & Swartz, P.C. are committed to the persistent and unrelenting pursuit of drug manufacturers who cause serious injury or death to unsuspecting consumers. If you or a loved one has been the victim of a dangerous drug and would like to speak with an attorney, please contact us; you can call us at (617) 742-1900, or if you are outside the Boston area, call toll-free at 1-800-545-3732. We are here to answer your questions and discuss how to protect your legal rights