Dialysis Concentrates Subject To Class 1 Recall By The FDA

Fresenius Medical Care is coming under greater scrutiny after the Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte dialysis concentrates and then sent multiple warning letters to the German company regarding the design, manufacture and distribution of some of its products. More alarmingly, details have emerged that Fresenius did not do enough to warn medical centers, the FDA or patients of the risks.

The Class I recall of GranuFlo Dry Acid and NaturaLyte Liquid dialysis concentrates was issued by the FDA in March 2012 after an internal memo from Fresenius was anonymously forwarded to the agency. The memo, which was sent to Fresenius Medical Care dialysis centers, warned of an elevated risk of cardiac arrest due to an increase in bicarbonate levels after using the concentrates. The memo stated that 941 hemodialysis patients had suffered a cardiac arrest in 2010 at 667 Fresenius dialysis facilities.

Class I Recalls

A Class I recall is reserved for medical devices that present the greatest danger to patients, and the FDA only issues such recalls when there is a likelihood of serious adverse health consequences or death. The internal memo described the findings as “troubling,” but no action was taken to alert the FDA.

The concentrates in question are administered to patients during dialysis to neutralize acid buildup in the blood. This type of concentrate contains acetate which the body converts to bicarbonate. However, the Fresenius concentrates contain far more acetate than comparable products, which leads to higher bicarbonate levels in patients. Elevated bicarbonate levels, known as alkalosis, significantly increases the risk of heart problems for people undergoing dialysis.

As a result of its failure to warn doctors and patients about the risks associated with using its products, the FDA raised questions about Fresenius, a company that treats about a third of the 400,000 dialysis patients in the United States. The German company operates their own dialysis clinics, and they are also a leading supplier of dialysis machines used in other facilities.

Repeated Warnings For Fresenius

Fresenius once again found themselves in the FDAs cross-hairs after the agency sent the company another warning letter in August 2013. This was their third such warning in less than a year. The latest warning was related to labeling issues and the complaint-handling procedures at a blood-bag manufacturing plant in Puerto Rico. Two months earlier, the company had voluntarily recalled some of its benztropine mesylate and magnesium sulphate injections because it was possible that the vials contained particles of glass. This followed on the heels of a warning letter sent by the FDA in March after an inspection of a plant producing cancer drugs in India.

Source:
http://www.renalbusiness.com/news/2012/06/fda-places-granuflo-naturalyte-under-serious-recall-category.aspx
http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=3&
http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf
http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm309990.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344711.htm
http://www.reuters.com/article/2013/08/26/us-fresenius-fda-idUSBRE97P0KI20130826