GranuFlo and NaturaLyte are Subject to an FDA Recall

A United States Food and Drug Administration (FDA) recall was implemented for the dialysis products GranuFlo and NaturaLyte, manufactured by Fresenius Medical Care labs.

The recall was issued after an internal Fresenius memo was brought to the attention of the FDA. The memo stated that the people who were being prescribed NaturaLyte and GranuFlo for use during dialysis treatments were suffering from increased instances of cardiac arrest, resulting in at least 941 instances of death throughout 2010.

The products are believed to be linked to metabolic alkalosis, a condition that can contribute to adverse medical conditions such as low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. These factors may lead to heart attack resulting from GranuFlo or NaturaLyte.

GranuFlo and NaturaLyte can cause metabolic alkalosis, which can result in cardiac arrest or death

NaturaLyte and GranuFlo are part of a multi-faceted hemodialysis treatment process. The products contain a substance that converts to bicarbonate, which helps clean the blood in a manner that is suitable for individuals who are experiencing kidney failure. However, at bicarbonate levels that are too high for human consumption, a patient may experience metabolic alkalosis, which may result in cardiac arrest or death.

While many kidney dialysis products contain this substance, NaturaLyte and GranuFlo contain it at higher levels than competing products.

Although GranuFlo was released on the market in 2003, clinicians did not suspect a link between the product, alkalosis, and cardiopulmonary death until several years later. Fresenius is currently under fire for failing to warn the consuming public of potential risks, such as death resulting from GranuFlo, for four months after it circulated the internal memo.

The resulting harm for Fresenius may be a series of lawsuits to address damages caused by the medical care organization’s failure to disclose potential risks.

The FDA institutes a Class 1 recall of NaturaLyte and GranuFlo—the highest level recall

The Fresenius internal memo expressly stated that “the major cause of metabolic alkalosis in dialysis patients is appropriately high dialysate total buffer concentration.” Such buffer concentration was then linked to the use of GranuFlo during kidney dialysis treatments. It then goes on to note that pre-dialysis metabolic alkalosis factors are associated with cardiopulmonary arrest.

After the FDA learned of the memo’s existence via a website called RenalWeb, the government organization issued an investigation into the drug to determine the risks. Several months later a Class 1 FDA recall for GranuFlo and NaturaLyte was enacted. Class 1 is the FDA’s highest level recall, to address concern over Fresenius dialysis injury and the use of the products and non-Fresenius clinics.

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