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Naturalyte and Granuflo Side Effects, Lawsuits And A Leaked Memo Spur An FDA Recall

Two products manufactured by the German company Fresenius—Naturalyte and Granuflo—were subject to a Class I recall recently in light of growing concerns over deadly adverse side effects from using Granuflo and Naturalyte.

Patients who have been given these substances during hemodialysis treatments have experienced low blood pressure, cardiac arrhythmia, and cardiac arrest. Due to the side effects, an increasing number of lawsuits against Fresenius have been filed across the country.

An FDA investigation as to the safety of Granuflo and Naturalyte

In light of multiple complaints involving side effects and the number of lawsuits being filed, the FDA began an investigation into the safety of both Natrualyte liquid and Granuflo powder concentrates. The agency anonymously received a copy of a memo Fresenius sent to its own clinics. The memo warned that these products were linked to 941 cases of cardiac arrest. However, the company never alerted the FDA or other clinics using the Fresenius products of the problem.

In addition to scrutinizing the products themselves, the FDA also investigated the actions of Fresenius for possible violations of federal regulations. In May, the FDA issued a Safety Alert regarding Granuflo and Naturalyte and their side effects. One month later, the agency issued the recall. The agency now requires Fresenius to notify health care providers and patients of the risk of side effects from the drugs.

In 2010, more than 900 deaths were associated with these products.

Metabolic alkalosis, side effects and symptoms after using Naturalyte

Naturalyte is a liquid concentrate that is combined with purified water and sodium bicarbonate to create a solution given to patients during hemodialysis. The substance is used to cleanse the patient’s blood during treatment. What makes Naturalyte and Granuflo unique is that both of these solutions also contain sodium acetate, which is converted into bicarbonate by the patient’s body. When bicarbonate levels get too high, it can result in a potentially deadly condition known as metabolic alkalosis. Increased bicarbonate levels can lead to other serious side effects, including those affecting the heart.

Those who have filed a lawsuit have claimed that the administration of Naturalyte during hemodialysis may result in the following symptoms, which can be indications of metabolic alkalosis:

• Nausea and vomiting

• Slowed respiration

• Rapid or irregular heartbeat

• Dangerous drop in blood pressure

• Irritability and confusion

When these symptoms appear, metabolic alkalosis may be to blame. Metabolic alkalosis can lead to a host of serious side effects, including:

• Decreased blood pressure

• Hypokalemia (low potassium levels)

• Hypercapnia (increased levels of carbon dioxide in the blood)

• Hypoxemia (low blood oxygen)

• Cardiac arrhythmias (irregular heartbeat)

• Naturalyte or Granuflo heart attack

• Cardiac arrest

• Sudden death

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