[gdlr_box_icon icon=”icon-legal” icon_type=”circle” icon_color=”#ffffff” icon_background=”#b7b173″ icon_position=”left” title=”ATTENTION:” ]The Ruth Law Team is currently accepting new cases for claims against the manufacture of the dialysis medication GranuFlo .[/gdlr_box_icon]
Dialysis Medication GranuFlo Recalled by FDA Due to Possible Fatal Side Effects
In March 2012, the Food and Drug Administration (FDA) issued a recall of GranuFlo based on evidence that it can cause heart attacks, strokes, and even death. GranuFlo is a dialysis drug which is manufactured by Fresenius Medical Care and performs multiple functions. It contains an ingredient that the body converts to bicarbonate, an alkaline substance that is used to neutralize acid build up in dialysis’ patients’ blood. GranuFlo contains more of this ingredient than other similar drugs and an excess of bicarbonate can cause heart problems such as heart attacks.
Fresenius Medical Center sent out an internal memo in November 2011, in which it warned its physicians about this possible risk. This memo also reported that in 2010, 941 patients in its clinics suffered from a cardiac arrest. After receiving this memo and performing its own investigation, the FDA issued a Class I recall of GranuFlo. Fresenius failed to offer this warning to patients and other facilities using GranuFlo.
For more information about this recall, please go to (insert hyperlink here for: Details About the FDA Recall of Dialysis Concentrates GranuFlo & Naturalyte)
[gdlr_toggle_box style=”style-1″ ]
[gdlr_tab title=”Background”]The FDA has issued a Class I recall on dialysis concentrates GranuFlo and Naturalyte after it found that the products could put patients at risk for cardiac arrest when not prescribed appropriately. Fresenius Medical Care is the largest operator of hemodialysis clinics in the U.S. and the largest supplier of dialysis machines and disposable products and supplies. Fresenius is under investigation for not warning its customers that its products GranuFlo and Naturalyte seemed to be contributing to an increase in the risk of patients suffering sudden cardiac arrests.
Early in 2012, Fresenius Medical Care voluntarily changed the labels on its NaturaLyte and GranuFlo products, an action the FDA has now declared to be a Class I recall. The Class I recall is for products manufactured from January 2008 until June 2012. While the GranuFlo recall will not involve removal of the products from the market, the FDA Class I recall indicates that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Fresenius has announced that it would continue its process to place updated labels on NaturaLyte and GranuFlo.
[gdlr_tab title=”How does GranuFlo Contribute to an Increased Risk in Heart Attacks?”]During hemodialysis, a machine filters toxic waste from the patient’s blood when their kidneys are no longer healthy enough to do this on their own. A necessary part of this process involves neutralizing acid that builds up in the blood by supplying the patient with an alkaline substance known as bicarbonate. It has been reported that doctors were not accounting for the additional bicarbonate contributed by GranuFlo when determining how much bicarbonate to administer separately. As a result, patients could be at risk for the effects of excessive bicarbonate, which has been linked to heart problems.[/gdlr_tab]
[gdlr_tab title=”Fresenius Aware of GranuFlo’s Risk of Cardiac Arrest Before Recall”]Fresenius reportedly carried out its own investigation and found that high serum bicarbonate levels increased a patient’s risk of cardiac arrest. According to a company memo, 941 patients treated at Fresenius’ own dialysis centers experienced cardiac arrest during 2010. An analysis of the data revealed that the patients’ risk of cardiac arrest was up to six times higher if they demonstrated high pre-dialysis bicarbonate levels. Despite this knowledge, Fresenius continued to aggressively market GranuFlo and routinely combined it with other products for pricing discounts, according to GranuFlo lawsuits.
The memo warned that the risk of cardiac arrest stemmed from the doctors’ failure to prescribe GranuFlo and NaturaLyte properly and should be “addressed urgently.” While this memo was circulated to its own dialysis centers in Nov. 2011, Fresenius reportedly did not warn customer clinics about potential heart issues. More than 100,000 dialysis patients were receiving the dialysis products at facilities not owned by Fresenius. The company only started to warn them in March 2012 after the FDA was leaked the memo. Even then, it has been alleged that the information shared with customers and clinics was unclear and lacked the details and urgency found in the company’s original, internal memo. In fact, it has been alleged that the memo contained only one of ten medical references mentioned in the internal memo and failed to discuss the most at-risk population. The FDA has launched an investigation to determine whether Fresenius broke federal laws when it failed to warn customers of the potentially deadly heart risk, according to The Times.[/gdlr_tab]