FRANKFURT, June 15 Fresenius Medical Care
(FMC) could face scrutiny from U.S. regulators for
failing to alert dialysis clinics of risks linked to one of the
drugs sold by the company, the New York Times reported.
In its online edition, the paper cites a U.S. Food and Drug
Administration official as saying he was "troubled" that FMC
only warned its own clinics of a link between its GranuFlo drug
for dialysis patients and a higher risk of deadly cardiac arrest
during the drug cleansing procedure.
FMC operates about a third of all U.S. dialysis centres for
patients with kidney failure, but it also supplies dialysis
machines and drugs to rival clinic operators there and in
The company, which makes almost two thirds of its revenues
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, the newspaper said.
"In light of these troubling findings," doctors should dose
more carefully, according to the memo, which also said that
"this issue needs to be addressed urgently".
Fresenius, did not alert non-FMC centres until late March,
after the FDA anonymously received a copy of the internal memo
and questioned the company about it, the Times reported.
The paper cited Steven Silverman, director of compliance for
the FDA's medical devices division, as saying he was "troubled
by the fact that Fresenius on its own initiative didn't notify
its entire customer base of this particular concern".
The chief medical officer for FMC in North America, Franklin
W. Maddux, told the paper the findings of the internal memo were
too preliminary to warrant a publication.
A spokesman for FMC, which is based in Germany, told Reuters
on Friday he would be able to comment later in the day.