Naturalyte Side Effects

Serious Side Effects of Naturalyte

The FDA has issued a Class 1 recall in response to reports of adverse reactions induced by this medication. Naturalyte may cause serious side effects such as metabolic alkalosis which can result in:

low blood pressure (hypotension)
low potassium levels (hypokalemia) with symptoms of weakened muscles, aching or cramping of the muscles, and an irregular heart rate
symptoms of insufficient levels of oxygen in the blood (hypoxemia): headaches, feeling restless, anxiety, feeling confused, or having memory problems
elevated levels of carbon dioxide in the blood (hypercapnia) which may cause headaches, fatigue and drowsiness, trouble focusing, dizziness, quickened breathing, muscle spasms, flushing of the skin, high blood pressure or rapid heart rate
arrhythmia or an irregular heartbeat

Consult your doctor immediately if you experience any of these symptoms as they may lead to serious injury or even death.

Warnings & Recalls for Naturalyte

FDA Class 1 Recall of Naturalyte

As of June 27, 2012, the U.S. Food and Drug Administration has issued a Class 1 recall of Naturalyte due to the potential for serious side effects and even death. Class 1 recalls indicate the highest level of danger or defect in products that may lead to severe side effects, injuries, or fatalities According to officials, hazards evolved from inappropriate administration amounts of doses which may have been prescribed. In the event of this error occurring, Naturalyte and other alkali can raise bicarbonate amounts within the body, as well as increase the risk of metabolic alkalosis (see "Side Effects" tab).

General Warnings

The FDA urges healthcare providers to prescribe Naturalyte with caution for hemodialysis. Along with the recall, changes in dosage amounts and prescriptions have been altered to reduce the risk of adverse reactions. Talk to your doctor about safely using Naturalyte.To learn more information about the recall, click here.

Naturalyte Treatment and Use

Naturalyte | Sodium Diacetate is a brand name liquid concentrate manufactured by Fresenius Medical Care to be used in treatments of acute or chronic renal (kidney) failure such as hemodialysis. Naturalyte Liquid Acid Concentrate may be used with a hemodialysis machine along with a dialyzer to cleanse blood.

Naturalyte has been recalled by the U.S. Food and Drug Administration as of June 2012 (see “Warnings and Recalls” tab).

How Does Naturalyte Work?

After kidney failure, the body is no longer able to remove waste, salts or fluids from the blood. Naturalyte works in combination with a 3-stream hemodialysis machine to effectively filter these products from the body.

Naturalyte Dosage Information

Dosage amounts vary depending on the patient and procedure type. Consult your doctor before receiving Naturalyte. Be sure to discuss the risks and benefits of using this medication. Do not take Naturalyte in any way other than what your doctor has prescribed to you.

Other Names for Naturalyte

Brand names:

Naturalyte Liquid Acid Concentrate

Generic name:

Sodium Diacetate Concentrate