Dialysis Patients At Possible Risk For Heart Attacks Following Use of GranFlo & Naturalyte

Risk For Heart Attacks Following Use of GranFlo & NaturalyteFor patients who receive dialysis, there is a new concern that they may be at risk for heart attacks. One of the types of products used in the dialysis procedure can lead to high bicarbonate levels within the body. This can lead to cardiovascular problems up to and including cardiac arrest or heart attacks. Until recently, this complication was widely unknown both to doctors and patents alike.

Overdosing Issues Relating To Common Medications Used To Reduce Acid Build Up

When a patient is undergoing dialysis, there are products that are used to reduce the acid build up in the patient’s blood. These products, such as GranuFlo and Naturalyte, can contain acetic acid, acetate and citrate that are converted to bicarbonate in the body. Many dialysis patients may also take medications that contain these same ingredients and by combining them, the patient may have levels of bicarbonate in their systems that are dangerous. High levels are attributed to heart problems, up to and including fatal cardiac arrest or heart attack.

GranuFlo Recall

Due to its risk to dialysis patient’s cardiovascular health, the FDA has now recalled a product called GranuFlo made by a German company called Fresenius Medical Care. Unfortunately, it was well after it was apparently known to cause risk to patients.

Back in November 2011, Fresenius, which is the largest operator of dialysis centers as well as the leading distributor of dialysis machines and products, sent an internal memo to its medical staff on the dangers of GranuFlo. The memo referred to the problems with the product leading to high levels of bicarbonate in patients and the risk of cardiac arrest. However, even though they notified their own staff, they did not warn the other companies that were purchasing GranuFlo from them of the risks. The product continued to be distributed and used in many dialysis centers.

It was not until the FDA received an anonymous copy of the internal memo in March 2012 that the problem with GranuFlo was brought to light. Concerned that Fresenius was aware there was a problem with their product yet did not warn their customers or the FDA, an investigation was started.  It was then that a notice was issued about possible issues with the products GranuFlo and Naturalyte and their possible affects on bicarbonate levels. In June 2012, the FDA issued a Class 1 recall to the public, placing both products in the high-risk category. Unfortunately this recall is too late for those who may have already passed from a heart attack or suffered heart damage from these medications.

Even with these products being recalled, the risk for bicarbonate overload is not necessarily over. Medical staff performing dialysis needs to be aware of bicarbonate concentrations in their patients to ensure they are not allowed to get to unacceptable risk levels. Since many different medications may contain ingredients that contribute to these levels, carefully monitoring them is essential for the patient’s health.

Attorneys Representing Patients In Dialysis Injuries

If your loved one suffered a heart attack or other type of injury following dialysis, you may have a legal claim against the facility. Our attorneys represent people who have suffered a various types of dialysis injuries including: falls, heart attacks and death. Contact Rosenfeld Injury Lawyers LLC today for a free legal consultation.