FRANKFURT (Reuters) – 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 cited 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 cardiac arrest during the drug cleansing procedure.
Last November, the German company sent a memo to dialysis centers 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 centers 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 all customers.
“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 Friday.
“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 company.
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 centers for patients with kidney failure, but it also supplies dialysis machines and drugs to rival clinic operators there and in Europe.
The company, which makes almost two thirds of its revenues in North America, is controlled by German healthcare conglomerate Fresenius SE & Co. KGaA.
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.