Fresenius Medical Care, a company that treats more than a third of the estimated 400,000 people in the U.S. who are currently receiving dialysis, is under fire after two of its products, GranuFlo and NaturaLyte, were linked to hundreds of heart attacks, some fatal.  In addition to a federal investigation, a number of GranuFlo and NaturaLyte lawsuits have been filed by people who allege the drugs were responsible for a loved one’s death.

Both GranuFlo and NaturaLyte are now the subject of a Class I recall, the U.S. Food & Drug Administration’s (FDA) most serious recall action. But according to a report published by The New York Times in June, internal documents indicate Fresenius knew of the GranuFlo heart attack risk by late 2011.  Unfortunately, only Fresenius-owned dialysis clinics were warned of the danger early on, while the thousands of facilities supplied by the company were left out of the loop until March 2012.

GranuFlo and NaturaLyte are acid concentrates used to neutralize the acid that builds up in the blood during dialysis.  Like similar drugs of this type, they contain an ingredient that the body converts to bicarbonate.  However, unlike rival products, GranuFlo and NaturaLyte contain more of this ingredient.  According to the Times, doctors had not been accounting for the extra bicarbonate contribution from GranuFlo when deciding how much bicarbonate to prescribe separately for dialysis treatments.   Too much bicarbonate in the body can result in alkalosis, a condition associated with an increase in cardiovascular death and catastrophic heart injuries in patients undergoing dialysis treatment.

According to The New York Times, Fresenius issued a memo to doctors at its own clinics in November 2011 warning that improper dosing of GranuFlo appeared to be contributing to a sharp increase in the risk of dialysis patients dying suddenly from cardiac arrest.  According to the GranuFlo warning, 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010.  The company’s medical staff had determined that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.

Nothing was done to notify doctors at Fresenius’ customer clinics about these problems.  It wasn’t until the FDA received an anonymous copy of the November memo that the company issued an Urgent Product Notification – this time with warnings applying to both GranuFlo and NaturaLyte – to those clinics.  In June, the FDA declared the Urgent Product Notification a Class I recall.

According to the Times, the FDA has since launched an investigation to determine if the delay in warning its customer clinics about the GranuFlo and NaturaLyte heart attack risk  violated federal regulations requiring companies to notify customers of potential dangers associated with a product.

“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the F.D.A.’s medical devices division, told the Times.

“Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”

Published October 11, 2012 by