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GranuFlo

GranuFlo Increases Heart Problems

GranuFlo and a similar product, NaturaLyte, are components of a dialysis treatment used in clinics around the world. Fresenius Medical Care manufactures GranuFlo. They also operate dialysis treatment clinics all over the United States in which the product is used. In June 2012, the Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte. This is due to the products’ link to potentially fatal cardiac arrest. But this serious risk was discovered long before.

Manufacturer Hides Risks from Patients

Fresenius circulated an internal document among its clinics in November 2011. The document stated GranuFlo patients have a 6 to 8 times increased risk of cardiopulmonary arrest and sudden cardiac death.

The company also noted that 941 incidents of cardiac arrest occurred among GranuFlo patients in Fresenius clinics in 2010. This figure does not even account for injuries sustained by patients who received GranuFlo in other clinics. Fresenius is the largest manufacturer of dialysis products. They treat more than one-third of the 400,000 Americans who receive dialysis annually.

At this time and until the memo was leaked to the FDA in March, Fresenius failed to warn their patients, doctors and the FDA about these horrifying risks. It is unknown how many lives were lost due to Fresenius’ negligence. Even one preventable death is unacceptable. According to The New York Times, The FDA is investigating whether Fresenius violated federal laws by failing to warn of the risks.

FDA Recalls Dangerous GranuFlo

The FDA issued a Class I recall of GranuFlo in June 2012. This level of recall is only implemented when there exists “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.”

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