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(USGovernment-News.Com, February 06, 2013 ) Phoenix, AZ -- Two popular drugs used by many kidney failure patients during dialysis have recently been issued a Class I recall by the Federal Drug Administration (FDA). Patients who undergo dialysis may have been put at risk for heart-related injuries, such as stroke or cardiac arrest. You may have also experienced other health issues such as low blood pressure or cardiac arrhythmia.
Goldberg & Osborne is familiar with all aspects of this major recall that potentially affects thousands of dialysis patients. Our experienced dangerous drug attorneys are knowledgeable about the latest developments and stand ready to assist those who feel they may have a case.
The issues leading to the recall can be traced back to improper dosing by health care professionals of GranuFlo or NaturaLyte during the dialysis process. The lack of proper dosing appears to have been directly related to improper labeling and lack of education by the products manufacturer, Fresenius Medical Care. Unfortunately, Fresenius chose to disseminate the required cautionary information to only their dialysis treatment centers and not to physicians outside of the network, in effect, putting thousands at unnecessary risk.
Fresenius Medical Care sold the products as NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. The two products can be used during dialysis treatment to help clean the patient’s blood.
However, GranuFlo and NaturaLyte have much higher bicarbonate conversion rates than other products of similar use. Bicarbonates are administered during dialysis to protect the patient from high acidic levels in the blood. Without proper labeling and education regarding the differences between GranuFlo & NaturaLyte, as compared to other products, physicians and other health care professionals were administering doses of bicarbonates which were too high. High doses of bicarbonates can put patients at significantly increased risk for heart-related injuries such as heart attacks.
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