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Complications from Granuflo

Granuflo, an acid concentrate used in kidney dialysis treatment, is designed to help filter blood in patients with kidney failure or kidney disease. While Granuflo was hailed as a drug essential in helping with dialysis, recent analysis has led to findings that Granuflo can cause a number of serious side effects. Most notably, Granuflo has been linked to a significant increase in a patient’s risk of heart attack and metabolic alkalosis, which in turn causes high blood pressure, hypokalemia, hypoxemia, and even cardiac arrhythmia.

Heart attacks are generally caused when one of the arteries pumping blood to the heart becomes blocked. The arteries can become narrow for a number of reasons, including buildup of various substances such as cholesterol. Heart attacks associated with Granuflo are characterized by the same symptoms as most other heart attacks. These symptoms include pressure, tightness, pain or aching in the chest or arms, nausea, indigestion or heartburn, shortness of breath, cold sweats, feelings of anxiety, trouble sleeping, dizziness, lightheadedness, or even trouble sleeping. While some experience very mild symptoms, other patients experience a wide range of severe symptoms. Heart attacks, especially ones with more severe symptoms, can be deadly.

In addition to causing heart attacks, Granuflo has been associated with a higher risk of metabolic alkalosis. Metabolic alkalosis is a condition in which the fluids of the body contain excess base, most commonly too much bicarbonate in the blood. Symptoms of the condition include confusion, hand tremors, light-headedness, muscle twitching, nausea or vomiting, numbness, or even prolonged muscle spasms. While the symptoms might seem mild, the complications involving alkalosis can be severe. Alkalosis can lead to arrhythmia, electrolyte imbalance, or in severe cases the patient can even slip into a coma.

Since findings of the potential serious consequences of using Granuflo have been discovered, the FDA has been quick to take action. In fact, the FDA promptly issued a Class I Recall of the drug. A Class I Recall is the most serious form of recall, and only involves situations which there is a reasonable probability that the use of the drug will cause severe health consequences or even death. The FDA warned that Granuflo can cause metabolic alkalosis, high blood pressure, hypokalemia, hypoxemia, or even cardiac arrhythmia, which can all lead to heart attacks. The FDA went on to say that Granuflo can have severe consequences, including death.1

Sources:

Granuflo Heart Attack Risk, Drug Dangers, http://www.drugdangers.com/granuflo/heart-attack.htm;
Heart Attacks During and After Dialysis Using Granuflo, Dialysis Advocates (Sep. 20, 2012) http://dialysisadvocates.com/category/granuflo/;
Latest Fresenius NaturaLyte, GranuFlo Dialysis Heart Attack Lawsuit Allegations Update: Attorneys Named to Lead Multidistrict Consolidated Cases, P.R. WEB (July 23, 2013) http://www.prweb.com/releases/2013/7/prweb10944794.htm;
Heart Attacks, MAYO CLINIC, http://www.mayoclinic.com/health/heart-attack/DS00094;
Alkalosis, MEDLINE PLUS, http://www.nlm.nih.gov/medlineplus/ency/article/001183.htm.

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