Deerfield, FL -- (SBWIRE) -- 05/15/2013 -- For those taking GranuFlo during kidney dialysis, thought they were taking a drug that would improve their quality of life. Instead, they took a drug that significantly increased the risk of heart problems, including cardiac arrest and cardiopulmonary death. In response to these deaths, the FDA issued a Class 1 recall of the drug in March 2012. Now, many people have filed GranuFlo lawsuits in order to get compensation for the wrongful death of their loved ones.
GranuFlo is a dry acid taken by patients on dialysis to neutralize acid build-up in the blood from dialysis. This build-up of acid, lactic acidosis, can cause nausea, vomiting, lethargy, anxiety, and other health problems. An acid neutralizer such as this is taken by most dialysis patients, meaning that hundreds of thousands of may have taken this drug at one time. Studies done to monitor the safety of this drug were undertaken by both the FDA and Fresenius, who both initially concluded the drug was safe.
The heart of the GranuFlow lawsuit is when Fresenius, the manufacturer of this drug, knew it to be unsafe for human consumption. In 2011, the company performed a study in which it examined the high rate of cardiac arrest in patients taking GranuFlow. They had observed these deaths as early as 2010, but the study was not concluded until November 4, 2011, when an internal memo was submitted to Fresenius' dialysis clinics. However, no action was taken by the manufacturer to warn the public or pull the drug off the market.
It was not until the FDA received an anonymous tip about this November 4, 2011 memo that it pushed the manufacturer to recall these drugs in order to prevent further death. The FDA found that increased levels of bicarbonate in the blood stream contributed to these heart problems, resulting in a risk of sudden cardiac death six times higher than those not taking the drug. And while the manufacturer sent out this warning to doctors at their Fresenius Medical Care clinics, they did not send it to doctors outside this network, resulting in approximately 100,000 people who may have continued taking this drug after its harmful effects were known.
Even in this memo, the plaintiff's attorneys involved in GranuFlo Settlements contend, there was no inadequate warning. It was a two page memo that contained many scientifically ambiguous terms and did not convey the seriousness with which this problem needed to be dealt with. From January 1 - December 31, 2010, Fresenius found that 941 patients had died from cardiopulmonary arrest, with those taking GranuFlow being at a significantly higher risk than patients taking other drugs. This failure to warn raised the risk of heart problems for hundreds of thousands of patients, the attorneys argue.
Currently, there are over 400,000 patients on kidney dialysis, with many of these patients having taken GranuFlo. Even after a patient has stopped taking the drug, the elevated bicarbonate levels may persist, putting them at a higher risk of heart disease, stroke, low blood pressure, and other health problems. If a patient has taken GranuFlo, they are urged to talk to their doctor and make sure the doctor is monitoring for any potential problems that may be caused by this drug.
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