Granuflo and Naturalyte Update: Death Count Rises

Granuflo and NaturaLyte lawyers at Pintas & Mullins Law Firm warn users of these dangerous dialysis drugs to stop taking the medications immediately. Shockingly, there were nearly 950 deaths in 2010 alone due to side effects of these fatal drugs.

Wrongful death lawsuits are already being filed by Granuflo and NaturaLyte users who suffered serious side effects. One Granuflo patient suffered cardiac arrest during dialysis treatment at an Ohio-based Fresnius medical center. His lawsuit alleges that the company failed to provide sufficient warnings about potentially dangerous Granuflo side effects, which ultimately caused his death.

The risk is widespread. Many Americans suffer from kidney problems, which compromises their health and requires them to need dialysis.. Fully functioning kidneys clean blood, regulate hormones, and keep bones strong.When kidneys fail, waste builds up in the body, blood pressure rises, and the body does not produce enough red blood cells. Dialysis is the most common method for treating Americans suffering from kidney failure.

NaturaLyte and Granuflo Dry Acid Concentrate are regularly used to supplement dialysis and have recently been recalled by the FDA in a Class 1 recall. Class 1 is the most serious FDA label and is only used when products pose a serious or immediate risk of adverse health effects or death. The recalling firm, Fresenius Medical Care North America, sent an Urgent Product Notification to their clinics and consumers earlier this year. It is speculated, however, that the firm knew of the possibly fatal health effects of their drug for years prior.

Fresenius Medical Center conducted tests on their GranuFlo and NaturaLyte in 2010 to evaluate possible risk factors. This study identified an astounding 941 patients with who died from cardiopulmonary arrests while taking the drug. The study, which was not released to the public, concluded that patients had a six times higher risk of cardiac arrest if their pre-dialysis bicarbonate levels were elevated. Fresenius Medical Care continued to manufacture and distribute the drug, without warning of these risks, through June 2012.

Granuflo and NaturaLyte have a high concentration of acetate or sodium diacetate, which can lead to high bicarbonate levels. In patients with already elevated biocarbonate levels, this concentration can be deadly, especially if doctors have not been warned of the high acetate intensity.

Fresenius Medical Center only notified those physicians and medical centers directly under their jurisdiction, about 667 facilities, and failed completely to notify other clinics and doctors who were using the products. RenalWEB reported that over 120,000 patients in non-Fresenius facilities were receiving the products. It was not until the memo reporting the findings of their study was leaked to the FDA that Fresenius released the Urgent Product Notification.

The New York Times reported that Fresenius medical officers said the findings of the internal memo were too preliminary to necessitate publication to other clinics. Cardiac death causes 59% of fatalities in dialysis patients, and any information associated with cardiac problems should be made public immediately. Other side effects caused by Granuflo and NaturaLyte include metabolic alkalosis, stroke, low blood pressure, hypokalemia, hypoxemia, hypercapina, and heart attack.

If you suffered a serious injury or the wrongful death of a loved one as the result of dialysis treatment with Granuflo or NaturaLyte, contact a personal injury attorney at Pintas & Mullins Law Firm immediately. We have decades of experiencing handling dangerous drug cases and obtaining maximum compensation for our clients. We are currently evaluating Granuflo and NaturaLyte lawsuits.


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