* Fresenius faces scrutiny for not telling all clinics of
* Company says GranuFlo memo based on preliminary findings
* Says meant to prompt further fact-finding within company
FRANKFURT, June 15 U.S. health regulators are
looking at whether Fresenius Medical Care violated any
rules by failing to alert dialysis clinics about risks linked to
one of its products.
Last November, the German company sent a memo to dialysis
centres that it operates in the United States, warning them
about a link between dosing errors with its GranuFlo product and
a higher risk of cardiac arrest.
But FMC did not send the memo to other U.S. dialysis centres
that may use GranuFlo, but are not operated by the company.
After learning of the memo in March, the U.S. Food and Drug
Administration asked Fresenius to broaden its notification to
"As in other cases in which FDA learns of product-related
hazards, we are evaluating whether Fresenius met its regulatory
responsibilities," FDA spokeswoman Morgan Liscinsky said on
"Should we determine that Fresenius did not do so, Fresenius
is subject to compliance action," Liscinsky said.
A spokesman for FMC, based at the group's German
headquarters, said the November memo was based on preliminary
findings and was meant to prompt further fact-finding within the
The FDA's March request was informal and subsequent talks
led to FMC informing all clinics, he said. "There is no formal
investigation by the FDA and we have no indication that there
will be one."
FMC operates about a third of all U.S. dialysis centres for
patients with kidney failure, but it also supplies dialysis
machines and supplies to rival clinic operators there and in
The company, which makes almost two thirds of its revenue
in North America, is controlled by German healthcare
conglomerate Fresenius SE & Co KGaA.
In a Nov. 4 memo to FMC's U.S. doctors, the company said
statistics point to doctors giving too much GranuFlo to some
patients, triggering cardiac arrest, according to the New York
Times, which reported on the issue on Thursday.
"In light of these troubling findings," doctors should dose
more carefully, the memo says, and "this issue needs to be