According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), close to 400,000 people in the United States undergo some form of dialysis treatment for end-stage renal disease (ESRD), which is a type of kidney failure. Dialysis can be life-saving as the process works to filter waste from the blood in place of the kidney function. Many people must remain on dialysis treatment until they receive notice of the availability of a kidney transplant.
Fresenius Medical Care is the primary U.S. dialysis provider and the company also manufactures drugs called dialysates that are key to regulating acid levels in the blood during dialysis. The powder form of acid concentrate, called GranuFlo, is the most prescribed drug of its kind on the market. While GranuFlo does neutralize acid in the blood, it can also lead to a dangerous increase in bicarbonate in the body, which can result in serious complications including heart attacks and strokes.
Manufacturers were aware of the dangers of GranuFlo dialysis drugs and heart attacks
In mid-2012, the Food and Drug Administration (FDA) issued a class I recall for GranuFlo and the liquid counterpart, NaturaLyte. The recall stated that these dialysis drugs cause dangerously high levels of bicarbonate in the blood, potentially leading to catastrophic or fatal heart events. Prior to the recall, however, there is evidence that Fresenius Medical Care knew of the possible dangers and continued to sell the pharmaceuticals.
Months before the recall, Fresenius had sent an internal memo to its own dialysis clinics warning of the risks of GranuFlo and heart attack, stating that it was an urgent matter. The company failed to warn any physicians or dialysis clinics outside of the company, however, and continued sales of GranuFlo to outside health centers. Fortunately, the memo was leaked to the FDA, which discovered the dangers and issued the recall.
There is no excuse for pharmaceutical companies to knowingly sell drugs that can injure users. At the law office of Michigan Injury Lawyers, we stand up for the rights of people who have suffered cardiac issues such as heart attack due to GranuFlo and dialysis drugs. Please discuss your case with an experienced dialysis heart attack lawyer by calling (888) 454-0801 today.