The FDA is investigating concerns over kidney dialysis products NaturaLyte and GranuFlo, manufactured by Fresenius Medical Care. These products, which are used during hemodialysis procedures to reduce acid buildup in blood, have been linked with serious NaturaLyte side effects, including heart rhythm problems and sudden cardiac arrest potentially leading to death.
The FDA anonymously received an internal company memo detailing the risks of these products, and is now checking to see whether or not Fresenius may have neglected to warn doctors and nurses in a timely manner. Patients may have been put at unnecessary risk, and now have grounds for a NaturaLyte lawsuit.
News of NaturaLyte Side Effects Late in Coming
Concerns first came to light regarding NaturaLyte side effects in early 2012. The FDA anonymously received a Fresenius internal memo that was dated November 4, 2011. The memo detailed a case-control study that examined the deaths of 941 patients at Fresenius dialysis centers. All died of cardiopulmonary arrest.
The study results showed that an elevated level of bicarbonate was a factor in these deaths. Like other similar concentrates, NaturaLyte contains ingredients that may be converted by the body into bicarbonate. Bicarbonate naturally reduces acid buildup in the blood during dialysis. NaturaLyte and GranuFlo can increase the risk for bicarbonate overdose because of how they are designed. Doctors apparently were unaware of this difference, and failed to adjust patient prescriptions.
Patients Unnecessarily Injured are Eligible for NaturaLyte Lawsuit
An overdose of bicarbonate can lead to a condition known as metabolic alkalosis. This is a pH imbalance in the body, and is a significant risk factor for low blood pressure, low blood oxygen, heart rhythm problems, and even cardiopulmonary arrest.
The November memo warned doctors of this issue, stating that it must be urgently addressed. Fresenius failed to warn outside medical centers, which also used NaturaLyte, about these concerns until the FDA received a copy of the memo and asked the company about it.
On March 29, 2012, Fresenius released a new memo to medical directors and nursing home managers, alerting them to the potential problems with NaturaLyte and GranuFlo. The FDA followed with their own warning on May 25, 2012.
Thousands of patients may have gone through dialysis procedures with NaturaLyte between November and March, and may have experienced serious NaturaLyte side effects. These patients may want to seek the advice of a NaturaLyte lawyer.
NaturaLyte Lawyer Notes June 2012 FDA Class I Recall
On June 27, 2012, the FDA posted an alert concerning a Class I recall of both the NaturaLyte and GranuFlo acid concentrates. The alert noted that both products were manufactured and distributed between 2008 and 2012.
“Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” the FDA stated. “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.”
A NaturaLyte Lawyer Can Help
If you suffered a serious cardiovascular injury after going through dialysis, and your doctor used NaturaLyte, you may benefit from a consultation with a NaturaLyte lawyer. A thorough review of the case may reveal claims that can be made against the manufacturer. If successful, a NaturaLyte lawsuit may result in monetary compensation. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.