July 31, 2012 · FLEMING | NOLEN | JEZ, L.L.P.
If you’ve recently undergone dialysis, you might have been given the recalled dialysates Naturalyte or Granuflo. Both dialysates were recalled by the FDA on June 27, 2012. Experts estimate that over 50% of all dialysis patients may be affected by the recall. The recall is a Class I – the most serious type.
How it started: Fresenius Medical Care of North America conducted an internal study from January 1 to December 31, 2010 examining the connection between use of their products – Granuflo and Naturalyte – and increased incidents of cardiac arrest. They found that patients with “elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with [a] 6 to 8 fold greater risk of cardiopulmonary arrest and sudden cardiac death.” Because Granuflo and Naturalyte increase bicarbonate levels beyond what was previously and commonly realized, patients’ bicarbonate levels spike during dialysis and metabolic alkalosis occurs. Metabolic alkalosis in turn causes heart failure.
Failure to warn: Fresenius’ former Chief Medical Officer, Dr. Hakim, issued the findings to over 1800 Fresenius clinics and “strongly recommend[ed] that physicians…give immediate attention to decreasing prescribed dialysate bicarbonate in patients with [a] pre-dialysis bicarbonate level of >24 mEq/L.” For reference, over 50% of dialysis patients have pre-dialysis bicarbonate levels of >24 mEq/L. However, 12 days after warning of the danger from Granuflo and Naturalyte, Fresenius fired Dr. Hakim and appointed a new Chief Medical Officer. Conspicuously, the memo was never released to the remaining clinics that use Granuflo and Naturalyte.
Fleming | Nolen | Jez, L.L.P believes dialysis patients had a right to know they were at a potential 500% to 700% increased risk for cardiopulmonary arrest. If you or a loved one has recently undergone dialysis, please contact the firm today for a free consultation and evaluation of your potential injury.
- FDA Recall: Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate, 29 Mar 2012
- Fresenius Medical Care Internal Memo, 4 Nov 2011