Fresenius Faces Second Dialysis Recall in Two Years Prompted by NaturaLyte Injury, Death Reports
For the second time in two years, a dialysis medication tied to serious cardiovascular side effects similar to those alleged in GranuFlo lawsuit claims has been named in serious injury and death reports filed with the U.S. Food and Drug Administration (FDA).
An FDA notice on May 21st indicates that the recall, which affected almost 60 batches of NaturaLyte Liquid Bicarbonate, was recently granted Class I status after they were discovered to have been contaminated with the bacteria, Halmonas. This Gram Negative bacteria is typically found in water with high salt concentrations.
According to a spokesperson for Fresenius, the FDA’s website was updated after receiving one report of death and two reports of injury allegedly sustained by dialysis patients who received NaturaLyte, a medication used in dialysis.
A report published June 2nd by Nephrology News.com indicates that Fresenius is currently investigating these reports. “This week, subsequent to the recall, the FDA updated its website with information that it received,” said a spokesperson for the company.
NaturaLyte Recall Affects Almost 60 Lots of Medication
According to the FDA’s website, the NaturaLyte recall was first issued on April 4, and affected 49 lots of the medication. Nine additional lots were flagged for bacterial contamination on May 1, before receiving Class I status on May 21. Class I is the most serious type of FDA recall and is only issued if the federal agency deems side effects associated with a medical product to be serious, and potentially life-threatening. On its website, the FDA ordered anyone with the recalled bottles of NaturaLyte to discontinue use immediately, place all units in a secure area and to perform a heat disinfectant program if the affected product was on the dialysis machine prior to patient treatment.
This is not the first time this dialysis drug has been involved in serious action from the FDA, though. In June 2012, NaturaLyte and GranuFlo, a similar medication, were subject to a recall after they became tied to sudden cardiac death, cardiopulmonary arrest, strokes, heart attacks and other serious heart problems. According to an Urgent Product Notification issued by Fresenius two months earlier, this may stem from the acid concentrates’ high amount of an ingredient the body converts to bicarbonate. This can cause metabolic alkalosis, a condition associated with cardiovascular problems, according to an alert from March 29, 2012.
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