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A Johnson & Johnson anemia drug tested in Germany on a panel of stroke patients is being
investigated by U.S.
health officials. They stated that the administration of said drug has caused a
high mortality rate in the German study patients.
More precisely, 16% of the patients who were administered
Eprex died three moths after the beginning of the study, in comparison with only
9% who took a Placebo, reads an FDA report on the matter. The purpose of the
study was to observe whether Eprex improved the brain’s function in stroke
patients, regardless of the fact that most of them did not suffer from anemia. They
were given either a high dosage of the drug or a Placebo, over a period of
three days. Moreover, the drug class that Eprex belongs to is traditionally
used (with FDA approval) in treating kidney diseases and various types of
cancer. Eprex itself, however, is only FDA approved in treating anemia.
Studies conducted in recent years have concluded that
patients who were given drugs from this class (ESAs - erythropoiesis-stimulating
agents) either developed tumor growths or had a smaller life-span. The FDA suggested
the German scientists should monitor this study and the patients involved more closely,
as half of the deceased passed away within seven days of the study’s beginning.
Other companies who produce and distribute ESAs do not
support these drugs being used in brain protection studies. To ensure a better
and more wide-spread awareness, the FDA compelled pharmaceutical companies to
provide more complete and informative warning on such drugs. Johnson &
Johnson representatives take responsibility over financing and supplying the
investigated drug, but deny any implication in designing or conducting the
trial study.
The FDA has not expressly concluded that the deaths are
solely caused by the high doses of Eprex and are currently looking into
discovering any underlying causes.
Image Credit: www.eprex.com
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