FDA Warns of Dangerous Kidney Dialysis Drugs

FDA Warns of Dangerous Kidney Dialysis Drugs | Pintas & Mullins Law Firm

Medicines are meant to heal and not damage. While that may sound too idealistic in the world of modern medicine where certain illnesses require drugs that may cause some other kind of harm to the body, pharmaceutical companies are expected to make people and concerned authorities aware of dangerous elements in their medicines.

Organizations such as the US Food and Drug Administration (FDA) and dangerous drug law firms exist for that purpose, to ensure that consumers are not taken for a ride by being deceived to consume potentially deadly medication.

GranuFlo and NaturaLyte are two dangerous drugs patients and hospitals need to be be cautious of. Administered as dialysis drugs, these dialysis drugs have caused cardiac arrest in about 941 patients of Fresenius clinics in 2010. There were also patients treated at other healthcare centers suffered heart attacks in 2010 after being administered these dialysis drugs. These were commonly prescribed to many kidney dialysis patients, at least around a third of the total number of patients in the country. The large number of cases led to the FDA issuing a Class 1 recall of GranuFlo and NaturaLyte, which is the most serious type of recall.

Research by Fresenius and investigations by the FDA led to the conclusion that these drugs could lead to many complications, including heart attack and death. Fresenius also came under attack for not warning the public and the FDA of the dangers early enough, in spite of being aware of them.

Fresenius Medical Care Centers is a major dialysis treatment company that administered these drugs to patients. Fresenius conducted research on these drugs and found out the dangerous element of the treatment. But apart from making the details known to its internal staff, the company never made public its revelations and 
even delayed revealing the observations to the FDA.

The FDA only came to know of the dangers of these dialysis drugs through a website known as RenalWeb, which revealed the existence of an internal memo containing details of the investigation conducted by Fresenius. The company released the information only about four months after the release of their internal memo, under intense pressure from the FDA. As a result, the FDA placed Fresenius under investigation and the company was punished. Medical malpractice lawyers watch out for such critical errors by major healthcare concerns.

GranuFlo and NaturaLyte are dialysis concentrates used to remove the toxins of the body as the patient’s kidneys do not perform the function normally. But in the process, these drugs also produce bicarbonate through a chemical reaction as a result of higher acetate content compared to other dialysis concentrates.

The sustained cardiac arrest caused by these drugs could lead to what is called a GranuFlo heart attack and eventually death. These risky situations can also be caused by mistakes made in dosing. The side effects caused by these are summed up as metabolic alkalosis. Metabolic alkalosis is a significant risk factor for stroke, cardiovascular issues, heart attack and even sudden death. The symptoms that make up metabolic alkalosis include:

• Hypoxemia or low oxygen in the blood • Hypokelameia or low potassium • Hypercapnia or high blood carbon dioxide • Cardiac arrhythmia • Low blood pressure 
All dialysis treatments and medications have this kind of conversion and chemical reaction, but the bicarbonate levels are much lesser than in these drugs. But GranuFlo and NaturaLyte apparently contain greater bicarbonate levels that become deadly for human consumption. There is hope though for victims of these potential deadly drugs, as well as family members of deceased patients. Experienced GranuFlo and NaturaLyte lawyers can help those affected get justice, and ensure that hospitals are made accountable for their mistakes.

Lawsuits have already been filed since the drugs were recalled. This should lead to more calls for justice. Wrongful death lawyers can help to ensure that patients are compensated for their injuries from dangerous kidney GranuFlo and NaturaLyte dialysis drugs.