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GranuFlo FDA Recall Cites Side Effects

The Food and Drug Administration issued a recall of the dialysis treatments known as GranuFlo and NaturaLyte, both of which are products manufactured by Fresenius Medical Care and are used in hemodialysis treatments for those patients whose kidneys are not functioning properly. A New York Times article noted that Fresenius Medical Care centers serve about a third of the nation’s kidney dialysis patients, which number in the thousands.

Complications related to products

Hundreds of dialysis patients who were being treated with either NaturaLyte or GranuFlo have reported serious side effects. These side effects include low blood pressure, shallow breathing, irregular heartbeat, seizures, cyanosis, confusion, and altered mental and emotional states. Some patients have suffered from heart attacks and other potentially fatal cardiac events after being administered either GranuFlo or NaturaLyte during the dialysis process.

GranuFlo and NaturaLyte are unique from other dialysis products in that they use an ingredient known as sodium dictate, which doubles the amount of acetate in the product compared to other formulations, which are made with acetic acid. Oftentimes, doctors were not aware in this difference in formulation. This means that many patients were administered too much of the product, which could result in a dangerous condition known as metabolic alkalosis.

After the Food and Drug Administration were made aware of an internal memo, circulated by Fresenius and later leaked to the FDA, that noted that 941 patients had suffered a heart attack resulting from GranuFlo in 2011 alone. As a result of this, the agency issued a FDA recall for GranuFlo in an effort to prevent a greater number of patients from suffering some of the serious side effects of the drugs.

GranuFlo lawyers help patients

Patients who have been injured by the side effects of either GranuFlo or NaturaLyte may choose to file suit against Fresenius with the help of an experienced personal injury lawyer. If you or your loved ones have suffered cardiac arrest or sudden death as a result of GranuFlo use, contact one of many experienced GranuFlo attorneys today.

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