Serious heart problems that could lead to death are being linked to the use of GranuFlo and NaturaLyte kidney dialysis products. Surprisingly, these alarming statistics are coming from internal documents that circulated in the offices of Fresenius Medical Care, the company that manufactures the drugs. Now circulating through numerous consumer-oriented web sites is a Fresenius memo that includes data about cardiac arrests suffered by over 900 patients who were being treated in 2010 in Fresenius clinics across the country. The number of cardiac incidents could actually be larger because the statistics in the memo do not include the large number of patients receiving Fresenius dialysis treatments in independent clinics.
Legal experts say that it is almost certain that lawyers for victims who have filed GranuFlo and NaturaLyte lawsuits will use the information contained in the memo to substantiate their claims the products had dangerous side effects that Fresenius did not adequately disclose. The GranuFlo and NaturaLyte victims claim in their lawsuits that they have suffered serious health problems because of the problems and would not have used them had they known that they were putting themselves at higher risk of suffering cardiac problems. Read more on the GranuFlo class action lawsuit
The scope of patients put at such risk is significant because, according to sales figures, Fresenius products are used by about one-third of the estimated 400,000 patients undergoing kidney dialysis in the country. How many patients use the products in other countries was not immediately known or addressed in the memo.
The products are used to treat patients who have kidney problems so serious that artificial means must be used to perform the critical function of kidneys: ridding the body of toxins. However, according to claims in the NaturaLyte and GranuFlo lawsuits, there can be chemical reaction in which dangerous levels of bicarbonates are released. In such cases, according to the allegations, a condition called metabolic alkalosis can occur which may cause life-threatening cardiac arrest.
Information contained in the internal Fresenius documents seem to indicate that many physicians were not aware of this complication that appears unique to GranuFlo and NaturaLyte, which could also give rise to allegations that Fresenius failed to warn health care professionals as well as patients about links to life-threatening problems that could be caused by use of the products.
The dangers associated with the use of NaturaLyte and GranuFlo caused the U.S. Food and Drug Administration to issue a Class 1 Recall of the products. Such recalls are issued only when life-threatening conditions occur.
In the recall, the FDA said: “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”