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Friday, Federal
Drug Administration officials announced the launch of an investigation on Amgen
and Johnson & Johnson’s experimental drugs for anemia. The latter company
revealed this month that the results of a German trial showed a higher death
rate in stroke patients who were given the drug than in the placebo-treated
group. The research was aimed at finding whether the medication could benefit a
stroke patient’s brain functions, although the FDA has only approved of Eprex’s
use in raising red blood cell levels in people who suffered from anemia.
A
number of 522 people, most of whom were not anemic (according to the FDA), were
given relatively high doses of the drug or a placebo over a period of three
days. Bleeding in the brain accounted for 4% of the deaths in the Eprex-group,
as opposed to 1% in those who had taken a placebo.
Three months after the study began, sixteen percent of those
who had received Eprex died (most of which within a week after the study ended), while the percentage in the other group was only
nine percent.
Anemia is the most common blood disorder worldwide, causing fatigue and
sometimes concentration problems. Since it leads to lack of oxygen in the
organs, its further clinical consequences spread over a large array of medical
conditions.
In a statement posted online, federal health regulators said
they would be looking into the risks and benefits of the drug’s experimental
use.
Amgen sells generically known epoetin alfa Exprex under the Epogen
name, while Johnson & Johnson comercializes the drug under the name of
Procrit.
The FDA informed that they expected to receive further data
within the following weeks and that it would make the resultsof their investigation public once their
review was finished.
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