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Results of a study undergone by German scientists revealed
that stroke patients given Amgen and Johnson & Johnson’s anemia drug Eprex
might increase their risk for death, the US Food and Drug Administration warned
on Friday.
Eprex belongs to a class called erythropoiesis-stimulating
agents, or ESAs, which were approved for patients with kidney disease and
cancer. The German study’s main goal was to see whether Eprex could improve
brain functions in stroke patients. This use of the drug has not been yet approved
in the US.
The study found that 16 percent of the 522 patients involved
died within 3 months, compared with 9 percent of those given a placebo. Considering
the study findings, the FDA decided to monitor patients enrolled in other
ongoing trials for adverse outcomes and evaluate whether the potential benefits
for enrolled patients outweigh the risks in these trials.
Johnson & Johnson last week alerted the FDA about the
study findings, spokesman Mark Wolfe said, adding that the company was doing
addition analyses to better understand the findings.
The FDA expects to receive more data on the study “within
the next several weeks.” Also, when the agency’s analysis is complete it will
“communicate our conclusions and recommendations to the public.”
Eprex is known generically as epoetin alfa. Johnson &
Johnson also sells epoetin alfa under the name Procrit. Amgen Inc sells a
version under the name Epogen. Amgen’s spokeswoman Emma Hurley said the company
is not supporting or sponsoring any studies of ESAs for brain protection and
has not found evidence of widespread use for that purpose.
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