NaturaLyte               

NaturaLyte Acid Concentrate is a product made by Fresenius Medical Care, a leading provider of kidney dialysis centers in the U.S. The product is used during hemodialysis procedures to help control acid buildup in the blood. The FDA has recently warned about this product, however, as it may be linked with serious NaturaLyte side effects such as heart problems and death. 

According to a May 25, 2012 safety communication, concentrates like NaturaLyte can contribute to elevated bicarbonate levels in kidney patients undergoing hemodialysis. These levels can then contribute to metabolic alkalosis, which is a significant factor associated with cardiopulmonary arrest.   

Doctors Unaware of NaturaLyte Side Effects

Patients with kidney problems often require dialysis procedures to clean their blood of waste material. NaturaLyte and similar concentrates are used in combination with a hemodialysis machine to remove waste from the blood. These products can contain acetic acid, acetate or citrate, which the body converts to bicarbonate.  Bicarbonate naturally reduces acid buildup in the blood.

Kidney patients may also take a separate prescription of bicarbonate. NaturaLyte may raise bicarbonate levels more than other similar products, especially when used on a patient taking a prescription bicarbonate.  Doctors need to be aware of the difference and adjust prescriptions accordingly.

As noted in a Fresenius company memo circulated November 4, 2011, however, many doctors were unaware of this difference.

NaturaLyte Lawyer May Note that the Company was Slow to Warn

Fresenius issued the November 2011 memo only to doctors at company run dialysis centers.  The memo detailed the results of a case-control study examining data from nearly 1,000 patients who died of cardiac arrest in Fresenius dialysis centers in 2010. Results showed that high bicarbonate levels were an independent risk factor for cardiovascular NaturaLyte side effects. Unfortunately for the public, Fresenius failed to send a similar warning to outside medical centers for five more months.

A bicarbonate overdose can lead to metabolic alkalosis, which is a pH imbalance in the body. Metabolic alkalosis is a significant risk factor associated with low blood pressure, hypoxemia (low blood oxygen), and heart rhythm problems. If not treated quickly, these symptoms may result in a heart attack and even death.

FDA Encourages Fresenius to Expand Warning

It was not until the FDA received an anonymous copy of the November 2011 memo, and asked Fresenius about it, that they released another warning to medical directors and nursing home managers.  The second warning alerted the public for the first time of the potential link between high bicarbonate levels and cardiovascular NaturaLyte side effects.

On May 25, 2012, the FDA released its own safety communication warning doctors about dosing errors that could occur with NaturaLyte and similar products. They noted that using concentrates that contain acetic acid and acetate can lead to elevated bicarbonate levels in patients, increasing risk of cardiopulmonary arrest.

On June 27, 2012, the FDA notified the public of a Class I recall of NaturaLyte and GranuFlo acid concentrates, stating that these products could cause serious adverse health consequences, including death.

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 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.